Associate Director - Statistics (Clinical Trial)
AbbVie
3 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical support for one or more clinical development projects; lead/develop statistical strategy for project development and regulatory submission.
- Lead statistical design, analysis, and reporting for clinical/scientific research programs; independently develop protocols and statistical analysis plans.
- Represent the function on project teams with statistical input to compound/drug development; partner with Clinical, Regulatory, Patient Safety, and/or GMA to create development strategies.
- Apply advanced statistical methodology; propose novel approaches; provide sufficient detail for programming implementation; ensure analyses in protocols/analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology/operations; may supervise contract or junior statisticians; support recruiting and training for professional development.
- Develop strategy for data presentation and inference; ensure interpretation of statistical deliverables; collaborate on publication; ensure accuracy/internal consistency of reports (tables, listings, figures).
- Serve as liaison for statistical issues on collaborative studies with CROs, academia, government agencies, committees, joint ventures, and licensing collaborators.
- Ensure regulatory requirements are met; critically review regulatory submission documents; participate in regulatory discussions; validate external statistical software for SOP and regulatory compliance.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or Mathematics.
- Clinical trials experience.
- High technical competence and excellent oral/written communication skills.
- Ability to identify data/analytical issues and develop solutions independently or via others.
- Ability to manage project timelines and quality of deliverables.
- Strong relationship-building with cross-functional partners; motivated to drive innovation.
- Leadership experience, including working/managing cross-cultural or overseas teams.
- Pharmaceutical or related industry knowledge, including drug development and life-cycle management in regulated environments.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.
Application instructions:
- Not provided in the job description text.
- Provide statistical support for one or more clinical development projects; lead/develop statistical strategy for project development and regulatory submission.
- Lead statistical design, analysis, and reporting for clinical/scientific research programs; independently develop protocols and statistical analysis plans.
- Represent the function on project teams with statistical input to compound/drug development; partner with Clinical, Regulatory, Patient Safety, and/or GMA to create development strategies.
- Apply advanced statistical methodology; propose novel approaches; provide sufficient detail for programming implementation; ensure analyses in protocols/analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology/operations; may supervise contract or junior statisticians; support recruiting and training for professional development.
- Develop strategy for data presentation and inference; ensure interpretation of statistical deliverables; collaborate on publication; ensure accuracy/internal consistency of reports (tables, listings, figures).
- Serve as liaison for statistical issues on collaborative studies with CROs, academia, government agencies, committees, joint ventures, and licensing collaborators.
- Ensure regulatory requirements are met; critically review regulatory submission documents; participate in regulatory discussions; validate external statistical software for SOP and regulatory compliance.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or Mathematics.
- Clinical trials experience.
- High technical competence and excellent oral/written communication skills.
- Ability to identify data/analytical issues and develop solutions independently or via others.
- Ability to manage project timelines and quality of deliverables.
- Strong relationship-building with cross-functional partners; motivated to drive innovation.
- Leadership experience, including working/managing cross-cultural or overseas teams.
- Pharmaceutical or related industry knowledge, including drug development and life-cycle management in regulated environments.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.
Application instructions:
- Not provided in the job description text.