465 Clinical Programmer jobs in the United States

Lead Clinical Programmer- FSP

27722 Durham, North Carolina Parexel

Posted 16 days ago

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Job Description

**PXL is seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the generation and delivery of quality biomarker samples and data.**
Responsibilities will include one or more of the following: development of tools and dashboards for sample/data tracking, review of clinical sample collection, resolving sample/data queries, and support of database lock (DBL) activities. Proficiency in Python, R, MATLAB, and/or SQL programming is required.
The candidate will develop, drive, and handle clinical study related tasks for the team in collaboration with Precision Medicine Companion Diagnostics Operations, Laboratory Managers and Clinical Laboratory Study Management. Expertise in one or more of the following areas is required: samples, kits, data, and logistics operations for clinical trials. Understanding of one or more of the following is preferred: central labs, specialty testing labs, data operations, database development, LIMS, kit inventory management and sample tracking processes.
Job Responsibilities:
- Establish and streamline processes to increase efficiency and implement analytical tools to advance departmental goals.
- Oversee operations, including samples, kits, and data processes, ensuring integrity and completeness for database locks.
- Use technical tools/systems and programming languages to systematically clean data, including processing confidential data according to guidelines.
- Programmatically aggregate and extract key information from operational reports
- Possess knowledge of structured data, such as entities, classes, hierarchies, relationships, and metadata, with the ability to perform data mapping
- Support processing of informed consent forms (ICFs) and ensure compliance with ICFs for internal sample handling, tracking, usage, and destruction.
- Manage sample-related issues with central and specialty labs, acting as the primary point of contact for resolution.
- Maintain and review metrics related to clinical study samples, data, kits, and logistics.
- Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial biosamples and data monitoring.
- Oversee and manage clinical trial biosamples and data monitoring and completeness from collection through to disposal, per requirements of the study
- Anticipate challenges, manage dependencies, and mitigate risks across projects.
- Enhance communication with senior stakeholders and align functions with group objectives.
- Participate in vendor oversight activities, including issue escalation, metrics reviews, and performance monitoring
**Job Requirements:**
- Proficiency in one or more programming languages (R, Python, Perl, SQL, MATLAB)
- Familiarity with APIs, database development, dashboard development, and Linux/Unix environments
- Ability to critically analyze and plan for sample interdependencies, risks, and issues with an awareness of the impacts to clinical studies/program.
- Strong problem-solving, project management, and organizational skills, with ability to effectively multi-task and prioritize.
- Extensive process development and project management experience including vendor management
- Excellent oral and written communication and presentation skills
- Advanced excel knowledge required
- 7+ years of experience in clinical operations preferred.
**Education:**
- Bachelor's or master's degree.
**Experience:**
- 6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Associate Director, Statistical Programming

99811 Juneau, Alaska Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

62762 Springfield, Illinois Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

80238 Denver, Colorado Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

96823 Honolulu, Hawaii Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

19904 Rising Sun, Maryland Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

06132 Hartford, Connecticut Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now
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Associate Director, Statistical Programming

72205 Little Rock, Arkansas Sumitomo Pharma

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

32395 Tallahassee, Florida Sumitomo Pharma

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now

Associate Director, Statistical Programming

85067 Phoenix, Arizona Sumitomo Pharma

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Lead on clinical studies and manage/provide training to team members when needed.
+ Contribute and implement statistical analysis plans; provide additional expertise in the
+ undefined
+ undefined
+ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
+ Work closely with Biostatistics to create analysis specifications following the instructions
+ undefined
+ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's
+ undefined
+ Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
+ Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate
+ undefined
+ Help identify issues and initiates resolution of the problems.
+ Act as a liaison between statistical programming, subcommittees and project teams as
+ undefined
+ May serve as an external spokesperson for the Statistical Programming Organization.
+ Create/acquire tools to improve programming efficiency or quality.
+ Establish monitoring of data transfers for ongoing trials to identify study conduct or data
+ undefined
+ Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
+ Perform other duties as assigned.
**Key Core Competencies**
+ Support End-to-End Statistical Programming using SAS
+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.
+ Executing Pinnacle 21 Checks
+ Knowledge about CDISC and Regulatory Guidelines
+ Demonstrate coaching skill to mentor Statistical Programmers
+ Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.
**Education and Experience**
+ Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.
+ Ability to use professional concepts to achieve objectives in innovative and efficient ways.
+ FDA submission experience is a must.
+ Solid knowledge of CDISC standard (SDTM & ADaM).
+ Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
+ Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
+ BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is $155,360 to $194,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
View Now
 

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