Executive Director, Biostatistics - Medical Affairs

Executive Director of Biostatistics, Medical Affairs Responsibilities:

• Provide statistical oversight for Medical Affairs biostatisticians and related work by internal biostatisticians and external consultants.
• Provide strategic statistical input for Medical Affairs studies, observational studies, and evidence-generation activities (partnering with RWE and HEOR).
• Oversee and contribute to completion of technical/operational statistical activities via internal/external resourcing.
• Build, develop, and lead the Medical Affairs Biostatistics team (structure, staffing, capability development, operating model).
• Anticipate projects; develop and assign staffing plans/resources based on priorities.
• Negotiate timelines across programs; coordinate limited resources to deliver quality outputs on time.
• Develop and ensure adherence to SOPs/BEDs and standards for Medical Affairs study conduct, methodology, analysis, and interpretation.
• Develop and train decision-enabled statistical tools; explore efficient/innovative statistical approaches.
• Ensure scientific integrity and maintain rigorous statistical standards.
• Empower biostatisticians to exercise judgment, use data-driven approaches, and follow best practices.
• Participate in cross-functional leadership meetings and represent Biostatistics.
• Set expectations (delegation, decision-making, communication) and provide constructive feedback.
• Develop talent action plans; retain top talent; address capability gaps.
• Coordinate processes/training with Biometrics leadership; assess compliance risks and support audit/inspection readiness.

• Excellent verbal/written communication; negotiation and interpersonal skills.
• In-depth drug development knowledge; strong commitment to GCP, ICH, and regulatory requirements.
• People leadership: supervise leads; delegate, coach, and develop career growth.
• Strong judgment/problem-solving; evidence-based decisions under limited information.
• Lead strategic initiatives; assess and improve processes/infrastructure.
• Influence senior leadership on biostatistics strategies; use competitive intelligence.
• Experience in Medical Affairs and observational/evidence-generation activities preferred.

• PhD and 12 years’ experience.

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

• Create inclusion; develop talent; empower teams.

• Salary range: $-$; may be eligible for discretionary annual bonus and stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance plans.