Analysis Oversight Statistical Programming Lead- Manager
Gilead Sciences
3 hours ago
Remote friendly (Raleigh, NC)
United States
Clinical Research and Development
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.
Minimum Required:
- 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.
- 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.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Benefits:
- Company-sponsored medical, dental, vision, and life insurance plans (eligibility subject to plan terms).
Application Instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
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.
Minimum Required:
- 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.
- 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.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Benefits:
- Company-sponsored medical, dental, vision, and life insurance plans (eligibility subject to plan terms).
Application Instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.