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. #J-18808-Ljbffr