Associate Director, Statistics
AbbVie
5 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Associate Director, Statistics
Responsibilities:
- Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
- Provide statistical leadership for design, analysis, and reporting for clinical or scientific research programs; independently develop protocols and statistical analysis plans (including product safety analysis plans/integrated summaries for GMA evidence generation).
- Represent the department on project teams to provide statistical input to compound/drug development and drive alignment with functional management; partner with Clinical, Regulatory, Patient Safety, or GMA to create development strategies.
- Demonstrate deep statistical methodology; propose novel methodological approaches with sufficient detail for programming implementation; ensure analyses in protocols and analysis plans are conducted appropriately.
- Train and mentor staff; may supervise contract/junior statisticians; assist with recruiting and training for professional development.
- Develop strategy for data presentation and inference; ensure correct interpretation of statistical deliverables; collaborate on publications; ensure accuracy and internal consistency of reports (tables/listings/figures).
- Serve as liaison on statistical issues for collaborative studies with CROs, academic institutions, government agencies, steering/data monitoring committees, joint ventures, or licensing collaborators.
- (Clin Stat) Ensure applicable regulatory requirements are met; critically review submission documents; participate in regulatory discussions as needed; validate external statistical software for SOP/regulatory compliance.
- (SSG) Lead benefit-risk planning and safety output development/delivery/interpretation (including graphics); define output specifications for pre-planned and ad hoc analyses.
- (SSG/GMA Stat) Lead safety statistics initiatives and/or support GMA Statistics to develop evidence-generation strategies (studies, presentations, publications) and provide life-cycle management input; support cross-functional communications.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
- High technical competence; excellent oral and written communication.
- Ability to identify data/analytical issues and provide solutions; manage project timelines and deliverable quality.
- Strong relationship-building with peers and cross-functional partners; motivated to drive innovation.
- Leadership experience managing cross-cultural/overseas teams.
- Pharmaceutical/regulated drug development and life-cycle management knowledge.
- (SSG) Experience leading safety-related projects (e.g., ISS, benefit-risk assessment, signal detection).
- (GMA Stat) Competence in experimental and RWE study design; descriptive/inferential statistics, statistical modeling, and statistical programming; knowledge of confounding control and bias minimization in observational studies preferred.
Responsibilities:
- Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
- Provide statistical leadership for design, analysis, and reporting for clinical or scientific research programs; independently develop protocols and statistical analysis plans (including product safety analysis plans/integrated summaries for GMA evidence generation).
- Represent the department on project teams to provide statistical input to compound/drug development and drive alignment with functional management; partner with Clinical, Regulatory, Patient Safety, or GMA to create development strategies.
- Demonstrate deep statistical methodology; propose novel methodological approaches with sufficient detail for programming implementation; ensure analyses in protocols and analysis plans are conducted appropriately.
- Train and mentor staff; may supervise contract/junior statisticians; assist with recruiting and training for professional development.
- Develop strategy for data presentation and inference; ensure correct interpretation of statistical deliverables; collaborate on publications; ensure accuracy and internal consistency of reports (tables/listings/figures).
- Serve as liaison on statistical issues for collaborative studies with CROs, academic institutions, government agencies, steering/data monitoring committees, joint ventures, or licensing collaborators.
- (Clin Stat) Ensure applicable regulatory requirements are met; critically review submission documents; participate in regulatory discussions as needed; validate external statistical software for SOP/regulatory compliance.
- (SSG) Lead benefit-risk planning and safety output development/delivery/interpretation (including graphics); define output specifications for pre-planned and ad hoc analyses.
- (SSG/GMA Stat) Lead safety statistics initiatives and/or support GMA Statistics to develop evidence-generation strategies (studies, presentations, publications) and provide life-cycle management input; support cross-functional communications.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
- High technical competence; excellent oral and written communication.
- Ability to identify data/analytical issues and provide solutions; manage project timelines and deliverable quality.
- Strong relationship-building with peers and cross-functional partners; motivated to drive innovation.
- Leadership experience managing cross-cultural/overseas teams.
- Pharmaceutical/regulated drug development and life-cycle management knowledge.
- (SSG) Experience leading safety-related projects (e.g., ISS, benefit-risk assessment, signal detection).
- (GMA Stat) Competence in experimental and RWE study design; descriptive/inferential statistics, statistical modeling, and statistical programming; knowledge of confounding control and bias minimization in observational studies preferred.