Manager, Statistics (Oncology) (On-Site)

Full Job Description

Job Description

Purpose:

The Manager, Statistics provides statistical expertise to support the research and development organization. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.

Responsibilities:

Protocols: Provide study design, calculate sample-size, develop randomization specifications and write statistical analysis plans to address study objectives. Ensure alignment of protocol with project and functional standards. Conduct quality review of protocol. Implement randomization schedules as planned with Interactive Response Technology vendor, Global Drug Supply Management, and other partners.

Database Activities: Assist in identifying scientifically appropriate data collection instruments. Ensure data collection is free of bias. Provide programming specifications for derived variables and analysis datasets. Assist with development and implementation of project-specific data standards. Identify and report data issues or violation of study assumptions. Guide programmers and data managers in preparing for database lock. Ensure accuracy of data released for statistical analysis.

Statistical Analyses: Explain statistical concepts to non-statisticians. Develop analysis plans ensuring statistical methods are appropriate with the study design with detail for programming. Ensures internal consistency of analysis plans. Perform statistical analyses per the SAP. Independently anticipate need and implement complex statistical methodology. Evaluate available statistical methodology and software and the need for novel statistical methodology.

Reports and Publications: With project team, develop strategy for data presentation and inference. With supervision, write statistical methods and other sections of protocols, publications, etc., ensuring document templates followed. Identify and implement corrections to flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses conducted as planned with accuracy and internal consistency of writing including tables, listings and figures.

Consultation: Work collaboratively with multi-function teams per agreed timelines. Timely inform management on important issues that may arise. Provide responses to questions from clients and independently pursue analyses suggested by data. Effectively and persuasively present statistical concepts, evidence and assessment of risks and impact. Communicate a basic understanding of scientific and regulatory principles for assigned projects.

External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with Academic and Contract Research Organizations. Communicate with statisticians outside PCYC concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department.

Training and Mentoring: Maintain technical skills and increase knowledge of new statistical methods and areas of application through scientific literature and professional meeting attendance. Present own research or review of literature at meetings.  Participate in departmental activities including recruiting, training/mentoring, research efforts and cross-functional collaborations, as needed.

Regulatory Activities: Participate with department management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies.

Compliance: Compliant with applicable corporate and divisional policies, procedures, and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to the Statistics function. Maintain department standards, GxP compliance, and best operating practices. Complete all assigned training on time.