Analysis Oversight Statistical Programming Lead- Manager
Gilead Sciences
June 24, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Analysis Oversight Statistical Programming Lead
Key Responsibilities:
- Provide strong statistical & programming expertise to influence decisions on statistical programming outputs and guide statistical programmers.
- Attend Study Management Team (SMT) meetings; provide functional input on programming activities and potential risks.
- Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
- Communicate SMT decisions, discussions, and action items to programmers.
- Review and approve key study documents; help programmers understand critical documents.
- Review programming timelines; negotiate with the study team as needed.
- Participate in internal/external audits; identify improvements to simplify procedural steps.
- Analyze vendor performance using KPIs/KQIs and participate in vendor governance as needed.
- Ensure adequate statistical programming resourcing for study milestones.
- Assign tasks to programmers based on experience/ability; track activities in task management systems.
- Maintain regular communications with study stakeholders on programming milestones.
- Support data/submission standards and templates.
- Perform quality checks to ensure deliverables are complete/accurate and comply with Gilead and CDISC standards (including correct execution order, validation documentation, folder locking, and TMF requirements).
- Surface needs for new/updated standards to improve efficiency/uniformity.
- Coach onboarding staff; oversee Data Issue Log entry and resolution prior to final production release.
- Hold analysis team meetings with biostatisticians.
- Serve as point-of-contact with vendors and liaise with other functions; request locking/archiving of study folders.
Minimum Required Education & Experience:
- Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.
Preferred Qualifications:
- 2+ years leading studies in Virology, Oncology, or Inflammation.
- Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs.
- Knowledge of GCP, ICH, and regulatory requirements for quality oversight/assurance and risk management.
- Strong non-compartmental PK programming experience.
- Ability to oversee programs for TQT, cQT, PK, and PD while ensuring adherence to protocols and regulatory submissions.
- Strong global collaboration, coaching/mentoring, and cross-functional leadership.
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.
Benefits (if explicitly stated):
- Eligible employees may participate in benefits plans (medical, dental, vision, and life insurance).
Key Responsibilities:
- Provide strong statistical & programming expertise to influence decisions on statistical programming outputs and guide statistical programmers.
- Attend Study Management Team (SMT) meetings; provide functional input on programming activities and potential risks.
- Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
- Communicate SMT decisions, discussions, and action items to programmers.
- Review and approve key study documents; help programmers understand critical documents.
- Review programming timelines; negotiate with the study team as needed.
- Participate in internal/external audits; identify improvements to simplify procedural steps.
- Analyze vendor performance using KPIs/KQIs and participate in vendor governance as needed.
- Ensure adequate statistical programming resourcing for study milestones.
- Assign tasks to programmers based on experience/ability; track activities in task management systems.
- Maintain regular communications with study stakeholders on programming milestones.
- Support data/submission standards and templates.
- Perform quality checks to ensure deliverables are complete/accurate and comply with Gilead and CDISC standards (including correct execution order, validation documentation, folder locking, and TMF requirements).
- Surface needs for new/updated standards to improve efficiency/uniformity.
- Coach onboarding staff; oversee Data Issue Log entry and resolution prior to final production release.
- Hold analysis team meetings with biostatisticians.
- Serve as point-of-contact with vendors and liaise with other functions; request locking/archiving of study folders.
Minimum Required Education & Experience:
- Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.
Preferred Qualifications:
- 2+ years leading studies in Virology, Oncology, or Inflammation.
- Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs.
- Knowledge of GCP, ICH, and regulatory requirements for quality oversight/assurance and risk management.
- Strong non-compartmental PK programming experience.
- Ability to oversee programs for TQT, cQT, PK, and PD while ensuring adherence to protocols and regulatory submissions.
- Strong global collaboration, coaching/mentoring, and cross-functional leadership.
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.
Benefits (if explicitly stated):
- Eligible employees may participate in benefits plans (medical, dental, vision, and life insurance).