Analysis Oversight Statistical Programming Lead- Manager
Gilead Sciences
August 13, 2026
Remote friendly (Raleigh, NC)
United States
Clinical Research and Development
Analysis Oversight Statistical Programming (AOSP) Lead
Key Responsibilities:
- Accountable for development of ADaM and Table/Figure/Listing (TFL) deliverables; ensure completeness, accuracy, and regulatory/quality compliance.
- Review vendor performance metrics; address challenges, risks, and bottlenecks.
- Lead programming output development within the Study Management Team (SMT): determine programming requirements, dependencies, timelines, and resourcing.
- Review/approve statistical programming requirements (e.g., ADaM Mapping Specifications) and key study documents; communicate SMT decisions/action items.
- Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards (including validation documentation, folder locking, TMF requirements; correct execution order).
- Monitor quality/timeliness of clinical trial programming deliverables; ensure issues/observations are resolved prior to final production release.
- Serve as point-of-contact with vendors and liaise with other functions; request locking/archiving of study folders; conduct analysis team meetings with biostatisticians.
Minimum Required Education/Experience:
- Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.
Preferred Qualifications / Skills:
- 2+ years leading studies in Virology, Oncology, or Inflammation; strong ADaM/TFL development expertise; proven delivery of high-quality datasets/outputs.
- Knowledge of GCP/ICH and regulatory requirements; coaching/mentoring; global collaboration; data-driven problem solving.
- Strong non-compartmental PK experience; oversee statistical programs for TQT, cQT, PK, PD; lead cross-functional teams.
Salary Range (base): Bay Area $146,540–$189,640; Other US $133,195–$172,370. May be eligible for bonus/long-term incentives; paid time off; medical/dental/vision/life insurance.
Application: Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).
Key Responsibilities:
- Accountable for development of ADaM and Table/Figure/Listing (TFL) deliverables; ensure completeness, accuracy, and regulatory/quality compliance.
- Review vendor performance metrics; address challenges, risks, and bottlenecks.
- Lead programming output development within the Study Management Team (SMT): determine programming requirements, dependencies, timelines, and resourcing.
- Review/approve statistical programming requirements (e.g., ADaM Mapping Specifications) and key study documents; communicate SMT decisions/action items.
- Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards (including validation documentation, folder locking, TMF requirements; correct execution order).
- Monitor quality/timeliness of clinical trial programming deliverables; ensure issues/observations are resolved prior to final production release.
- Serve as point-of-contact with vendors and liaise with other functions; request locking/archiving of study folders; conduct analysis team meetings with biostatisticians.
Minimum Required Education/Experience:
- Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.
Preferred Qualifications / Skills:
- 2+ years leading studies in Virology, Oncology, or Inflammation; strong ADaM/TFL development expertise; proven delivery of high-quality datasets/outputs.
- Knowledge of GCP/ICH and regulatory requirements; coaching/mentoring; global collaboration; data-driven problem solving.
- Strong non-compartmental PK experience; oversee statistical programs for TQT, cQT, PK, PD; lead cross-functional teams.
Salary Range (base): Bay Area $146,540–$189,640; Other US $133,195–$172,370. May be eligible for bonus/long-term incentives; paid time off; medical/dental/vision/life insurance.
Application: Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).