Executive Director, Biostatistics - Medical Affairs

Executive Director of Biostatistics (Medical Affairs)

Reporting to the Head of Biometrics, leads Biostatistics for Medical Affairs studies across all therapeutic areas; builds, scales, and leads a high-performing Biostatistics team.

• Provide statistical oversight for Medical Affairs biostatisticians and external consultants.
• Deliver strategic statistical input for Medical Affairs studies, observational studies, and evidence-generation (with RWE/HEOR).
• Oversee technical/operational statistical activities via internal/external resource management.
• Build and lead the Medical Affairs Biostatistics team (structure, staffing plans, capability development, operating model).
• Anticipate projects, develop staffing plans, and manage resources by priorities.
• Negotiate timelines across programs; coordinate limited resources to deliver quality outputs on time.
• Ensure adherence to SOPs/BEDs and standards for Medical Affairs study conduct, methodology, analysis, and interpretation.
• Develop decision‑enabled statistical tools; pursue efficient/innovative approaches.
• Maintain scientific integrity and rigorous statistical standards.
• Provide leadership/feedback and define delegation/decision‑making/communication frameworks.
• Develop talent action plans; assess capability gaps; coordinate compliance, audit, and inspection readiness as applicable.
• Represent Biostatistics in cross‑functional leadership meetings; provide support beyond core portfolio as needs evolve.

• Excellent verbal/written communication; negotiation and interpersonal skills.
• In-depth drug development knowledge; strong commitment to GCP, ICH, and regulatory requirements.
• Proven people leadership (supervise leads; delegate, coach, develop).
• Strong judgment and problem‑solving; evidence‑based decision‑making with limited information.
• Ability to lead strategic initiatives and improve processes/infrastructure.
• Ability to advise senior leadership on biostatistics strategy; competitive intelligence.
• Preferred: experience in Medical Affairs, observational studies, and/or broader evidence generation.

• PhD and 12 years’ experience.

• PhD in Biostatistics (or equivalent) and 16+ years industry experience.

• Salary range: $–$; may include discretionary annual bonus, stock‑based long‑term incentives, paid time off, and benefits (medical/dental/vision/life insurance).