Analysis Oversight Statistical Programming Lead- Manager

Analysis Oversight Statistical Programming Lead – Clinical Data Science (CDS)
Key Responsibilities

• Provide statistical & programming expertise to influence decisions on statistical programming outputs and guide statistical programmers.
• Attend Study Management Team (SMT) meetings; contribute on programming activities and risks.
• Review/approve statistical programming requirements (e.g., ADaM Mapping Specifications) and communicate decisions/action items to programmers.
• Review/approve key study documents; help programmers understand critical documents.
• Review programming timelines and negotiate adjustments with the study team.
• Support internal/external audits; identify opportunities to refine/simplify procedures.
• Assess vendor performance using KPIs/KQIs and participate in vendor governance discussions.
• Ensure adequate statistical programming resourcing; assign tasks based on experience/ability.
• Track programming activities in the task management system; maintain milestone communications with stakeholders.
• Influence/support data and submission standards, templates, and perform quality checks for completeness/accuracy/compliance (Gilead and CDISC).
• Ensure correct execution order; ensure validation documentation, folder locking, and TMF requirements.
• Surface/update standards to improve efficiency and uniformity.
• Manage data issue logging and ensure issues are resolved prior to final production release.
• Hold analysis team meetings with biostatisticians; serve as point-of-contact with vendors and other functions; request study folder locking/archiving.

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

• Minimum 2 years leading studies in Virology, Oncology, or Inflammation.
• Mature statistical knowledge; strong ADaM/TFL development expertise.
• Proven track record delivering high-quality statistical programming datasets/outputs.
• Deep knowledge of GCP, ICH, and regulatory requirements (quality oversight/assurance/risk).
• Strong non‑compartmental PK analysis experience; ability to oversee TQT, cQT, PK, and PD program development.

Create inclusion, develop talent, and empower teams.

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