Associate Director, Statistics
AbbVie
5 months ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical leadership for regulatory submissions and product life-cycle management strategy planning and implementation for assigned projects; develop protocols and statistical analysis plans (including safety analysis plans/integrated safety summaries for GMA evidence generation).
- Represent the statistics function on project teams to provide statistical input to compound/drug development and align with functional management; partner with Clinical, Regulatory, Patient Safety, and/or GMA to create development strategies.
- Apply advanced statistical concepts and methodology; propose novel statistical approaches; provide sufficient detail for programming implementation; ensure analyses in protocols and analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology and operations; may supervise contract or junior statisticians; support recruiting and professional development.
- Develop strategy for data presentation and inference; ensure correct interpretation of statistical deliverables; collaborate on scientific publications; ensure report/publication accuracy and internal consistency (tables/listings/figures).
- Serve as liaison for statistical issues on collaborative studies with CROs, academics, government agencies, monitoring committees, joint ventures, and licensing collaborators.
- (Clin Stat) Meet regulatory requirements; critically review regulatory submission documents; participate in regulatory discussions; validate external statistical software for SOP and regulatory compliance.
- (SSG) Lead benefit-risk planning and assessment; develop and interpret safety outputs (including graphics) and define output specifications for pre-planned and ad hoc requests.
- (Safety/SSG) Implement safety-statistics strategic initiatives to improve interpretation, monitoring, assessment, and reporting of safety data.
- (GMA Stat) Support/lead GMA strategies for evidence generation (studies, presentations, publications); provide lifecycle management input; support communications and cross-functional collaboration.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
- Strong technical competence and excellent oral/written communication.
- Ability to identify data/analytical issues and propose solutions.
- Ability to manage timelines and deliver high-quality work.
- Strong leadership skills; experience working/managing cross-cultural or overseas teams.
- Pharmaceutical industry knowledge, including drug development and life-cycle management in regulated environments.
- (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.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees.
Application instructions:
- Not specified in the provided text.
- Provide statistical leadership for regulatory submissions and product life-cycle management strategy planning and implementation for assigned projects; develop protocols and statistical analysis plans (including safety analysis plans/integrated safety summaries for GMA evidence generation).
- Represent the statistics function on project teams to provide statistical input to compound/drug development and align with functional management; partner with Clinical, Regulatory, Patient Safety, and/or GMA to create development strategies.
- Apply advanced statistical concepts and methodology; propose novel statistical approaches; provide sufficient detail for programming implementation; ensure analyses in protocols and analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology and operations; may supervise contract or junior statisticians; support recruiting and professional development.
- Develop strategy for data presentation and inference; ensure correct interpretation of statistical deliverables; collaborate on scientific publications; ensure report/publication accuracy and internal consistency (tables/listings/figures).
- Serve as liaison for statistical issues on collaborative studies with CROs, academics, government agencies, monitoring committees, joint ventures, and licensing collaborators.
- (Clin Stat) Meet regulatory requirements; critically review regulatory submission documents; participate in regulatory discussions; validate external statistical software for SOP and regulatory compliance.
- (SSG) Lead benefit-risk planning and assessment; develop and interpret safety outputs (including graphics) and define output specifications for pre-planned and ad hoc requests.
- (Safety/SSG) Implement safety-statistics strategic initiatives to improve interpretation, monitoring, assessment, and reporting of safety data.
- (GMA Stat) Support/lead GMA strategies for evidence generation (studies, presentations, publications); provide lifecycle management input; support communications and cross-functional collaboration.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
- Strong technical competence and excellent oral/written communication.
- Ability to identify data/analytical issues and propose solutions.
- Ability to manage timelines and deliver high-quality work.
- Strong leadership skills; experience working/managing cross-cultural or overseas teams.
- Pharmaceutical industry knowledge, including drug development and life-cycle management in regulated environments.
- (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.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees.
Application instructions:
- Not specified in the provided text.