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Executive Director, Biostatistics - Medical Affairs

Gilead Sciences
11 days ago
Remote friendly (Raleigh, NC)
United States
Medical Affairs
Executive Director of Biostatistics (Medical Affairs)

Responsibilities
- Provide statistical oversight of biostatisticians and biostatistics work supporting Medical Affairs, including internal resources and external consultants.
- Provide strategic statistical input for Medical Affairs studies, observational studies, and evidence-generation activities (in partnership with RWE and HEOR).
- Oversee and complete technical and operational statistical activities via management of internal and external resources.
- Build, develop, and lead the Medical Affairs Biostatistics team (structure, staffing plans, capability development, operating model).
- Anticipate projects and develop staffing plans; assign and manage resources based on priorities and strategy.
- Negotiate project timelines across programs with competing priorities; manage limited resources to deliver quality outputs on time.
- Develop and ensure adherence to SOPs, BEDs, and departmental standards for study conduct, methodology, analysis, and interpretation.
- Champion decision-enabled statistical tools and identify efficient/innovative statistical approaches.
- Ensure scientific integrity and maintain rigorous statistical standards.
- Provide expectations, delegation, decision-making, and communication framework; deliver constant constructive feedback.
- Develop talent action plans; address capability gaps using internal/external resources.
- Coordinate managerial activities with Biometrics leadership; assess compliance risks and ensure audit/inspection readiness.
- Provide leadership support beyond the core Medical Affairs portfolio as needs evolve.

Capabilities and Skills
- 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 team leads; delegate, coach, provide feedback, and support career development.
- Strong judgment/problem-solving for complex situations and evidence-based decisions with limited information.
- Experience influencing senior leadership on biostatistics strategy and evidence-generation approaches.

Basic Qualifications
- PhD and 12 years of experience.

Preferred Qualifications
- PhD in Biostatistics (or equivalent) and 16+ years industry experience.

Benefits
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility varies), paid time off, and company-sponsored medical, dental, vision, and life insurance plans.

Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.