Associate Director, Statistics - Immunology
AbbVie
4 months ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical support for clinical development projects; lead/develop statistical strategy for project development and regulatory submission.
- Lead statistical design, analysis, and reporting for clinical or scientific research; independently develop protocols and statistical analysis plans.
- Represent the statistics function on project teams; provide statistical input to drug development and align with cross-functional management (Clinical, Regulatory, Patient Safety, GMA, etc.).
- Apply advanced statistical concepts/methodology; propose novel statistical approaches; provide sufficient detail for programming implementation; ensure analyses are conducted per protocols/analysis plans.
- Train/mentor staff; 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; maintain report/publication accuracy and internal consistency.
- Serve as liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, committees, joint ventures, or licensing collaborators; build external scientific connections.
- Ensure regulatory compliance; critically review regulatory submission documents; participate in regulatory discussions as needed; validate external statistical software for SOP and regulatory compliance.
Significant Work Activity:
- Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hr day).
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 drive solutions.
- Ability to manage project timelines and deliverable quality.
- Strong leadership; experience leading cross-cultural/overseas teams; relationship-building with cross-functional partners.
- 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; confounding control and bias minimization in observational studies preferred.
Benefits (if applicable/explicit):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k); eligible for short-term and long-term incentive programs.
- Provide statistical support for clinical development projects; lead/develop statistical strategy for project development and regulatory submission.
- Lead statistical design, analysis, and reporting for clinical or scientific research; independently develop protocols and statistical analysis plans.
- Represent the statistics function on project teams; provide statistical input to drug development and align with cross-functional management (Clinical, Regulatory, Patient Safety, GMA, etc.).
- Apply advanced statistical concepts/methodology; propose novel statistical approaches; provide sufficient detail for programming implementation; ensure analyses are conducted per protocols/analysis plans.
- Train/mentor staff; 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; maintain report/publication accuracy and internal consistency.
- Serve as liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, committees, joint ventures, or licensing collaborators; build external scientific connections.
- Ensure regulatory compliance; critically review regulatory submission documents; participate in regulatory discussions as needed; validate external statistical software for SOP and regulatory compliance.
Significant Work Activity:
- Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hr day).
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 drive solutions.
- Ability to manage project timelines and deliverable quality.
- Strong leadership; experience leading cross-cultural/overseas teams; relationship-building with cross-functional partners.
- 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; confounding control and bias minimization in observational studies preferred.
Benefits (if applicable/explicit):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k); eligible for short-term and long-term incentive programs.