Executive Director, Biostatistics - Medical Affairs

Executive Director of Biostatistics (Medical Affairs)

Responsibilities

• Provide statistical oversight of biostatisticians supporting Medical Affairs and biostatistics work by internal biostatisticians and external consultants.
• Provide strategic statistical input for Medical Affairs studies, observational studies, and evidence-generation activities (with RWE and HEOR).
• Oversee completion of technical and operational statistical activities via internal/external resourcing.
• Build, develop, and lead the Medical Affairs Biostatistics team (structure, staffing plans, capability development, operating model).
• Anticipate projects; develop staffing plans; assign/manage resources by priorities and business strategy.
• Negotiate timelines across programs and coordinate limited resources to deliver quality outputs on schedule.
• Develop and ensure adherence to SOPs, BEDs, and departmental standards for study conduct, methodology, analysis, and interpretation.
• Develop and train decision-enabled statistical tools; pursue efficient/innovative approaches.
• Ensure scientific integrity and rigorous statistical standards across the portfolio.
• Provide feedback and clarity on expectations, delegation, decision-making, and communications.
• Develop talent action plans; assess capability gaps and address via internal/external resources.
• Coordinate managerial processes/training with Biometrics leadership; support compliance risk assessment and audit/inspection readiness.
• Provide leadership support beyond the core Medical Affairs portfolio as needs evolve.

Capabilities/Skills

• Excellent verbal/written communication; negotiation and interpersonal skills.
• In-depth drug development knowledge; commitment to GCP, ICH, and regulatory requirements.
• Proven people leadership: supervise leads, delegate, coach, provide career development.
• Strong judgment/problem-solving; evidence‑based decisions under limited information.
• Ability to lead strategic initiatives and drive process/infrastructure improvements.
• Experience advising senior leadership on biostatistics strategy; use competitive intelligence.

Qualifications

• PhD and 12 years’ experience.
• Preferred: PhD in Biostatistics (or equivalent) and 16+ years industry experience.
• Preferred: Medical Affairs and/or observational studies and broader evidence‑generation experience.

Benefits

• Salary range: $302,005.00–$390,830.00. May be eligible for discretionary annual bonus, discretionary stock‑based long‑term incentives, paid time off, and company‑sponsored medical, dental, vision, and life insurance.