Associate Director - Statistics (Clinical Development)

Responsibilities:
- Provide statistical leadership for regulatory submission and product life-cycle management strategy planning/implementation for assigned projects; independently develop protocols and statistical analysis plans (including product safety analysis plans/integrated summary/analysis plans for GMA evidence generation).
- Provide statistical input to compound/drug development; represent function/department on project teams and 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 and plans are conducted appropriately.
- Train/mentor staff on statistical methodology and operations; may supervise contract/junior statisticians; support recruiting/training for professional development.
- Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables; collaborate on scientific publications; maintain accuracy/internal consistency of reports (tables/listings/figures).
- Liaise on statistical issues for collaborative studies with CROs, academic/government institutions, committees, joint ventures, and licensing collaborators; build external scientific connections.
- (Clin Stat) Ensure regulatory requirements are met; critically review regulatory submission documents; participate in regulatory discussions; validate external statistical software for SOP/regulatory compliance.
- (SSG) Lead benefit-risk planning/assessment and safety outputs (including graphics); define output specifications for pre-planned and ad hoc safety analyses.
- (SSG/GMA Stat) Implement safety-statistics initiatives to improve safety data interpretation/monitoring/reporting, efficiencies, and consistency; support/lead GMA evidence generation strategies (studies, presentations, publications) and life-cycle management input; drive cross-functional collaboration.

Qualifications:
- Minimum: MS (10+ years) or PhD (6+ years) in Statistics/Biostatistics or related field.
- Strong leadership; experience working/managing cross-cultural/overseas teams.
- Pharmaceutical or related industry knowledge in drug development and regulated life-cycle management.
- Experience leading safety-related projects (e.g., ISS, benefit-risk assessment, signal detection).
- Competence in experimental and real-world evidence (RWE) study design; descriptive/inferential statistics; statistical modeling; statistical programming.
- Preferred: Observational-study confounding control and bias minimization methodologies.
- Other required: High technical competence; excellent oral/written communication; ability to identify and resolve data/analytical issues; manage project timelines and deliverable quality; build relationships with peers/cross-functional partners; motivated to drive innovation.

Benefits:
- Comprehensive benefits including paid time off (vacation/holidays/sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible for short-term and long-term incentive programs.

Application instructions:
- Not specified in the job description.