Analysis Oversight Statistical Programming Lead- Manager
Gilead Sciences
August 13, 2026
Remote friendly (Parsippany, NJ)
United States
Clinical Research and Development
Analysis Oversight Statistical Programming Lead
Key Responsibilities (including, but not limited to):
- Exhibit strong statistical & programming knowledge to influence key decisions and guide statistical programmers.
- Attend Study Management Team (SMT) meetings; provide input on programming activities, risks, and actions.
- Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
- Communicate SMT decisions to programmers; review and approve key study documents.
- Help programmers understand critical study documents; review and negotiate programming timelines.
- Participate in internal/external audits; identify opportunities to refine/simplify procedures.
- Analyze vendor performance using KPIs/KQIs and participate in governance discussions.
- Ensure adequate statistical programming resourcing; assign tasks based on experience/ability.
- Track programming activities in task management system; maintain milestone communications with stakeholders.
- Influence/ support data and submission standards and templates.
- Perform quality checks to ensure complete/accurate deliverables compliant with Gilead and CDISC standards (including correct execution order, validation documentation, folder locking, and TMF requirements).
- Surface needs for new/updated standards; provide prioritization decisions and coaching.
- Ensure issues are logged and resolved prior to final production release.
- Hold analysis team meetings with biostatisticians; serve as point-of-contact with vendors/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:
- Minimum 2 years leading studies in Virology, Oncology, or Inflammation Therapeutic Area.
- Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs.
- Knowledge of GCP, ICH, and regulatory requirements (quality oversight/assurance and risk management).
- Strong data analysis, critical thinking, and problem-solving; non-compartmental PK programming experience.
- Ability to oversee TQT, cQT, PK, and PD statistical program development; lead/mentor cross-functional teams.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Benefits:
- Company-sponsored medical, dental, vision, and life insurance plans (eligibility per plan terms).
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities (including, but not limited to):
- Exhibit strong statistical & programming knowledge to influence key decisions and guide statistical programmers.
- Attend Study Management Team (SMT) meetings; provide input on programming activities, risks, and actions.
- Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
- Communicate SMT decisions to programmers; review and approve key study documents.
- Help programmers understand critical study documents; review and negotiate programming timelines.
- Participate in internal/external audits; identify opportunities to refine/simplify procedures.
- Analyze vendor performance using KPIs/KQIs and participate in governance discussions.
- Ensure adequate statistical programming resourcing; assign tasks based on experience/ability.
- Track programming activities in task management system; maintain milestone communications with stakeholders.
- Influence/ support data and submission standards and templates.
- Perform quality checks to ensure complete/accurate deliverables compliant with Gilead and CDISC standards (including correct execution order, validation documentation, folder locking, and TMF requirements).
- Surface needs for new/updated standards; provide prioritization decisions and coaching.
- Ensure issues are logged and resolved prior to final production release.
- Hold analysis team meetings with biostatisticians; serve as point-of-contact with vendors/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:
- Minimum 2 years leading studies in Virology, Oncology, or Inflammation Therapeutic Area.
- Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs.
- Knowledge of GCP, ICH, and regulatory requirements (quality oversight/assurance and risk management).
- Strong data analysis, critical thinking, and problem-solving; non-compartmental PK programming experience.
- Ability to oversee TQT, cQT, PK, and PD statistical program development; lead/mentor cross-functional teams.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Benefits:
- Company-sponsored medical, dental, vision, and life insurance plans (eligibility per plan terms).
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.