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Executive Director, Biostatistics - Medical Affairs

Gilead Sciences
5 hours ago
Remote friendly (San Francisco Bay Area)
United States
Medical Affairs
Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Medical Affairs will lead the Biostatistics function for Medical Affairs studies across all therapeutic areas and will build, scale, and lead a high-performing Biostatistics team for the Medical Affairs portfolio.

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 (in partnership with RWE and HEOR).
- Oversee and contribute to completion of technical/operational statistical activities via management of internal/external resources.
- Build, develop, and lead the Medical Affairs Biostatistics team (structure, staffing, capability development, operating model).
- Anticipate emerging projects; develop staffing plans; assign/manage resources by priorities.
- Negotiate project timelines and coordinate limited resources to deliver quality outputs on schedule.
- Develop and ensure adherence to SOPs, BEDs, and standards for study conduct, statistical methodology, data analysis, and interpretation.
- Champion decision-enabled statistical tools and pursue efficient/innovative approaches.
- Ensure scientific integrity and maintain rigorous statistical standards across the portfolio.
- Represent Biostatistics in cross-functional leadership meetings.
- Provide biostatistician expectations, constructive feedback, and talent action plans.
- Coordinate managerial processes/training with Biometrics leadership; assess compliance risks and support audit/inspection readiness.
- Provide leadership beyond Medical Affairs as additional biostatistics/biometrics priorities evolve.

Capabilities & Skills:
- Excellent verbal/written communication; negotiation and interpersonal skills.
- Strong drug development knowledge with commitment to GCP, ICH, and regulatory requirements.
- Proven people leadership: delegate, coach, provide feedback, support career development.
- Excellent judgment and evidence-based decision-making in complex situations.
- Lead strategic initiatives; assess and improve processes/infrastructure.
- Integrate planning across departments and drive change.
- Advise senior leadership on biostatistics strategies; use competitive intelligence.
- Experience in Medical Affairs and/or observational studies/evidence generation (preferred).

Basic Qualifications:
- PhD and 12 years’ experience.

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

Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.