477 Clinical Programmer jobs in the United States

Hybrid worker - 50% on-site

This position will be dedicated to the Clinical Data Warehousing & Delivery function within the Clinical Data Reporting & Analytics group and contribute to the improvement of clinical data review, cleaning efficiency and formal statistical analyses by providing innovative and forward-thinking Extract Transform and Load (ETL) solutions. Responsible for planning, connecting to the different data sources, designing and developing the mappings, scheduling those mappings within the Clinical Data Warehouse, monitoring and maintaining the ETL process within the Clinical Data warehouse.

Key Responsibilities and Major Duties
• Leverage technical expertise to define feasible solutions and understand limitations.
• Can create/develop prototypes for new solutions as applicable.
• Create best practices for data loading, transformation, and extraction.
• Develop data architecture, data modeling, and ETL mapping solutions within structured data warehouse environment.
• Develop and implement ETL routines according to the Data Warehouse (DWH) design and architecture.
• Support the development and validation required through the lifecycle of the DWH, maintain user connectivity and provide adequate security for data warehouse.
• Monitor the DWH systems performance and integrity; provide corrective and preventative maintenance as required.
• Maintain data integrity and traceability across the transformation lifecycle from the Source to Target

Qualifications
1. 8+ years of experience with any ETL tool.
2. Minimum 5+ years of experience in SQL language.
3. Minimum 3+ years of experience with cloud technologies.
4. Minimum 3+ years of experience in SAS programming.
5. Minimum 5+ years of experience in shell scripting.
6. Good to have experience with ECS (eClinical Solution) ETL tool.

Education: Minimum bachelor's degree in computer science

• Serve as a subject matter expert and provide expertise for Database programming, Reporting, and Technology and optimize the use of J-Review, ETL, SAS tools, and others to support business needs.
• Manage the quality of the data management clinical database programming deliverables including edit checks programming, complex reports, and listings; patient profiles, subject narratives, exception listings, dose modification reports, and other adhoc reports using JReview & SAS as part of standard data validation and reporting package for clinical studies.
• Develop and/or provide oversight on the programming specifications for the data validation and reporting deliverables; code, test, and document deliverables conforming to programming standards, data quality and governance, and validation policies.
• Partner with internal and external stakeholders to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of visualization tools.
• Design and develop macros, applications, and other utilities to expedite JReview/SAS programming activities.
• Develop standard programs, templates, reports, data listings, discrepancy reports, and patient profiles to facilitate in the ongoing review of clinical data during study conduct and study closeout.
• Build, test, and scale-up programs for data validation derivation procedures, data reports, listings, and SAS on Demand relational database extracts for operational use, identification of data outliers, quality inconsistencies, and preparation for analysis.
• Provide technical guidance and direct programming tasks for Medical Coding activities.
• Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including interim analysis, and database lock activities.
• Perform ETL tasks, enhancements, validation, and maintenance of the programs and templates on an ongoing basis.
• Perform QC, lead unit testing activities, develop validation scripts for user acceptance, manage and execute programs and dry runs as needed, and resolve programming issues proactively.
• Develop and maintain mapping, and program specifications for standard reports, listings, and visualizations.
• Maintain database programming checklists and trackers to ensure conformance of high-quality deliverables with the study data validation and reporting package.
• Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
• Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.

• Minimum of 5 years database programming experience and data validation programming in the device/pharmaceutical/CRO industry.
• Expertise in Clinical Programming, methods, and techniques
• Expertise in using standard reporting and data visualization tools including JReview, and SAS tools.
• Knowledge of industry standard clinical technologies including CTMS, EDC (RAVE, InForm)
• Knowledge of CDISC data standards.
• Knowledge and understanding of relational databases.
• Clinical Programming, Project Management, and Technical Expertise
• Knowledge of logical data design and data mapping
• Knowledge of reporting and data visualization tools: JReview, Spotfire, SAS suite and ETL technology
• Experience with programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.
• Proficient in industry standards, medical terminology, and clinical trial methodologies.

• Bachelor of Science degree in Computer Science, Mathematics, or related area with relevant experience
• Other degrees and certifications considered if commensurate with related data management experience

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

We are seeking a Manager of statistical programming to join our rapidly growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, Program Management and others.

Responsibilities

• Review of analysis plans for appropriate methodologies;
• Review of clinical data as SDTM dataset;
• Development of analysis databases (ADaM);
• Programming of study analyses and review of study results;
• Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation;
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis;
• Assist in efforts to identify, develop and implement departmental standards, applications, processes and training; and
• Assist in identifying consultants and the selection of service providers and oversees statistical and programming deliverables by CROs or service providers.

• Master's degree in Biostatistics or a related field
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development;
• Proficiency in the use of statistical software including SAS, and familiarity of the use of R studio;
• Excellent verbal and written communication skills; Effective in communication and team collaboration, influencing across different functional lines;
• Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post -approval activities;
• Experience interacting with and overseeing programming services of CRO vendors; and
• Knowledge of cross-functional department functions/roles within a drug development company.

• Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Serves as a project lead to provide oversight on multiple outsourced aggregated product level safety analyses projects. Acts as a fluent programmer in sophisticated Clinical Safety Surveillance analyses projects. Independently identifies issues in the analysis and assures project quality consistency. Acts as a stakeholder in multi-functional discussion on project scope, milestone, and project timeline negotiation.

Project Involvement

• Acts as lead programmer for multiple projects.

• May serves as project leader.

• Overseeing vendor project activities and deliverables

Key Differentiating Contribution

• Generates or oversees the production of statistical output (e.g., tables, listings) for aggregated compound level safety projects.

• Actively share experiences and discuss possible process enhancements at programming meetings.

• Recommends potential trainings.

• Independently identifies issues in the analysis from previous experience and knowledge.

• Provides consistency and quality assurance across various studies.

Promotional Criteria

• A promotion from this position may be recognition for sustained performance and high potential.

• Demonstrates strong project management skills including ability to anticipate time, resources and staffing required to successfully complete multiple projects.

Training and Development Opportunity

• Attend a conference or class related to SAS, eCTD, CDISC, project management training.

Job Responsibility and Skills

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.

• Generates or oversees the production of programming deliverables (e.g., tables, listings) for safety analysis reports and to support process improvement initiatives.

• Exhibits strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.

• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.

• Must be able to lead and manage multiple concurrent projects.

• Excellent verbal and written communication skills and interpersonal skills are required.

• Has a thorough understanding of clinical trials design and reporting process.

• Knowledge of clinical safety (DSUR/PSUR, IB RSI, RMP, CSS) reporting requirements is a plus.

• Has the ability to resolve study related issues and conflicts within a therapeutic project.

• Can create buy-in and has the ability to negotiate timelines.

• Uses internal macros or writes SAS® macros to automate deliverables.

• Responsible for harmonizing source data across multiple studies, creation and validation of Analysis Datasets and TLFs for all safety deliverables following department standards.

• Analyze vendor performance through assessment of Key Performance and Quality Indicators (e.g. KPI, KQI), metrics, and results.

• Serves as the point-of-contact with vendors, and liaisons with other functions.

• Understanding of CDISC Standards (SDTM and ADaM).

Minimum Qualifications:

• 6 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.

OR

• 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.

The salary range for this position is: $133,195.00 - $172,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

• Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas.
• Coordinate programming documentations and specifications for multiple studies following programming standards and processes.
• Demonstrate company values and act as a role model by demonstrating excellence, competence, collaboration, innovation, respect, ownership, and accountability.
• Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.
• Act as a technical resource for programming group to provide advice on complex programming tasks, standards, and processes.
• Support global regulatory authority submissions including preparing programming deliverable for submission and working closely with partnering functions to address health authority request.
• Participate and contribute towards department goals and SME topics.

• Bachelors in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 8+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.
• Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. is a plus.
• Understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e. understanding of statistical concepts, techniques and clinical trial principles) and good knowledge of regulatory submissions and requirements.
• Ability to work on global interdisciplinary teams.
• Good organizational, interpersonal, communication, and leadership skills.
• Establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability to effectively manage multiple tasks and projects.
• Problem solving and innovative skills that demonstrate initiative and motivation.
• Ability to influence others, mentor, and coach junior programmers to achieve results.

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

We are seeking a Manager of statistical programming to join our rapidly growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, Program Management and others.

Responsibilities

• Review of analysis plans for appropriate methodologies;
• Review of clinical data as SDTM dataset;
• Development of analysis databases (ADaM);
• Programming of study analyses and review of study results;
• Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation;
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis;
• Assist in efforts to identify, develop and implement departmental standards, applications, processes and training; and
• Assist in identifying consultants and the selection of service providers and oversees statistical and programming deliverables by CROs or service providers.

Requirements:

• Master's degree in Biostatistics or a related field
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development;
• Proficiency in the use of statistical software including SAS, and familiarity of the use of R studio;
• Excellent verbal and written communication skills; Effective in communication and team collaboration, influencing across different functional lines;
• Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post -approval activities;
• Experience interacting with and overseeing programming services of CRO vendors; and
• Knowledge of cross-functional department functions/roles within a drug development company.

Preferred:

• Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications

California pay range

$145,000—$165,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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