Associate Director - Statistics (Clinical Development)
AbbVie
5 hours ago
Remote friendly (North Chicago, IL)
United States
$137,500 - $261,000 USD yearly
Clinical Research and Development
Responsibilities:
- Provide statistical leadership for regulatory submissions and product life-cycle management; develop protocols and statistical analysis plans (including safety analysis plans/integrated summaries for GMA evidence generation).
- Represent Statistics on project teams; provide statistical input for compound/drug development and align with cross-functional partners (Clinical, Regulatory, Patient Safety, GMA).
- Apply advanced statistical methodology; propose novel approaches; ensure protocol/analysis-plan analyses are conducted appropriately.
- Train/mentor staff; may supervise contract/junior statisticians; support recruitment and training for professional development.
- Develop strategy for data presentation and inference; support interpretation, publication, and accuracy/consistency of reports (tables/listings/figures).
- Serve as liaison for statistical issues on collaborative studies with CROs, academics, government agencies, committees, joint ventures, and licensing collaborators.
- (Clin Stat) Meet regulatory requirements, review submissions, discuss with regulators, and validate external statistical software for SOP/regulatory compliance.
- (SSG) Lead benefit-risk planning and safety output development/interpretation; implement Safety Statistics Group initiatives to improve safety data characterization, efficiency, and consistency.
- (GMA Stat) Support/lead strategies for evidence generation (studies, presentations, publications) and lifecycle management input.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics/Biostatistics or related field.
- Leadership experience managing cross-cultural/overseas teams.
- Pharmaceutical/regulatory drug development and life-cycle management knowledge.
- Experience leading safety projects (ISS, benefit-risk, signal detection).
- Competence in experimental and RWE study design, descriptive/inferential stats, statistical modeling, and statistical programming.
- Preferred: confounding control and bias minimization methods in observational studies.
- Required: strong oral/written communication; identify analytical issues and drive solutions; manage timelines/quality; build cross-functional relationships and drive innovation.
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k); eligibility for short- and long-term incentive programs.
- Provide statistical leadership for regulatory submissions and product life-cycle management; develop protocols and statistical analysis plans (including safety analysis plans/integrated summaries for GMA evidence generation).
- Represent Statistics on project teams; provide statistical input for compound/drug development and align with cross-functional partners (Clinical, Regulatory, Patient Safety, GMA).
- Apply advanced statistical methodology; propose novel approaches; ensure protocol/analysis-plan analyses are conducted appropriately.
- Train/mentor staff; may supervise contract/junior statisticians; support recruitment and training for professional development.
- Develop strategy for data presentation and inference; support interpretation, publication, and accuracy/consistency of reports (tables/listings/figures).
- Serve as liaison for statistical issues on collaborative studies with CROs, academics, government agencies, committees, joint ventures, and licensing collaborators.
- (Clin Stat) Meet regulatory requirements, review submissions, discuss with regulators, and validate external statistical software for SOP/regulatory compliance.
- (SSG) Lead benefit-risk planning and safety output development/interpretation; implement Safety Statistics Group initiatives to improve safety data characterization, efficiency, and consistency.
- (GMA Stat) Support/lead strategies for evidence generation (studies, presentations, publications) and lifecycle management input.
Qualifications:
- MS (10+ years) or PhD (6+ years) in Statistics/Biostatistics or related field.
- Leadership experience managing cross-cultural/overseas teams.
- Pharmaceutical/regulatory drug development and life-cycle management knowledge.
- Experience leading safety projects (ISS, benefit-risk, signal detection).
- Competence in experimental and RWE study design, descriptive/inferential stats, statistical modeling, and statistical programming.
- Preferred: confounding control and bias minimization methods in observational studies.
- Required: strong oral/written communication; identify analytical issues and drive solutions; manage timelines/quality; build cross-functional relationships and drive innovation.
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k); eligibility for short- and long-term incentive programs.