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Sr Manager, Statistical Programming

Gilead
Foster City, CA; Raleigh, NC
HybridUSD 169,320 - 219,120 / year

About this role

About the Role We are seeking a Sr Manager, Statistical Programming to join Gilead's Statistical Programming–Analysis Programming team. This role collaborates with Clinical Development and external vendors to ensure timely, high-quality analysis datasets and statistical outputs for study reports and integrated summaries in support of regulatory, scientific and business objectives. This hybrid role is based in Foster City, CA or Raleigh, NC. What You'll Do

  • Collaborate with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Generate or oversee the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries.
  • Anticipate resource needs; direct the design and/or coding of analysis files.
  • Ensure programming and corresponding documentation are completed in a manner consistent with departmental procedures; provide primary and secondary programming support as needed.
  • Implement strategic initiatives and communicate effectively with stakeholders; interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
  • Maintain thorough understanding of clinical trial design, reporting processes, and regulatory submissions (FDA, PMDA, EMA, and other global agencies).
  • Work across multiple therapeutic areas and support integrated analyses for regulatory submissions and post-filing activities. What We're Looking For
  • Education and experience: BS in Biostatistics/Computer Science or equivalent with 8+ years in pharma/biotech OR MS with 4+ years OR PhD with 2+ years.
  • Strong knowledge of clinical programming and regulatory requirements; experience with FDA and global submissions is preferred.
  • Proficiency in SAS programming, development of SAS Macros, and advanced CDISC standards (CDASH, SDTM, ADaM).
  • Proven ability to manage time-sensitive, complex tasks and interact with multiple departments.
  • Excellent interpersonal, communication, problem solving, and analytical skills. Nice to Have
  • Prior experience in oncology, hematology, virology, and inflammation.
  • Hands-on experience with pivotal studies and regulatory submissions (NDA, BLA, MAA, etc.).
  • Deep understanding of regulatory requirements relevant to statistical programming (GCP, ICH).
  • Extensive experience with fast-turnaround programming activities. Compensation & Benefits
  • Salary range: $169,320.00 - $219,120.00.
  • Eligible for discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary by role), paid time off, and comprehensive benefits (medical, dental, vision, life insurance).
  • Benefits information available at the Gilead careers compensation-benefits-and-wellbeing page.

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