Analysis Oversight Statistical Programming Lead- Manager

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.

• Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.

• 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.

• Create inclusion, develop talent, and empower teams.

• Company-sponsored medical, dental, vision, and life insurance plans (eligibility per plan terms).