Analysis Oversight Statistical Programming Lead- Manager
Gilead Sciences
10 days ago
Remote friendly (Parsippany, NJ)
United States
Clinical Research and Development
Analysis Oversight Statistical Programming (AOSP) Lead
Responsibilities:
- Accountable for ADaM and Table/Figure/Listing (TFL) deliverables; ensure completeness, accuracy, and regulatory/quality compliance.
- Review/approve statistical programming requirements (e.g., ADaM Mapping Specifications) and key study documents; communicate decisions/action items.
- Lead programming output development within the Study Management Team; attend SMT meetings; manage timelines and study programming dependencies.
- Provide quality management: perform QC checks, ensure correct execution order, validation documentation/folder locking/TMF compliance.
- Monitor quality/timeliness of deliverables; track activities in task management systems; manage data issues and Data Issue Log resolution prior to final release.
- Analyze vendor performance (KPI/KQI), participate in vendor governance, and address risks/bottlenecks.
- Ensure adequate resourcing, assign tasks, coach/mentor onboarding staff; hold analysis meetings with biostatisticians.
- Serve as primary point of contact with vendors and liaison with other functions; request locking/archiving of study folders.
Qualifications:
- Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.
Preferred:
- 2+ years leading studies in Virology, Oncology, or Inflammation; mature ADaM/TFL expertise.
- GCP/ICH and regulatory knowledge (quality oversight/assurance/risk management); strong data analysis and critical thinking.
- Strong non-compartmental PK programming experience; experience guiding TQT/cQT/PK/PD programs and cross-functional teams.
Benefits (if applicable): Company-sponsored medical, dental, vision, and life insurance plans.
Application: For Current Gilead Employees and Contractors, apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Accountable for ADaM and Table/Figure/Listing (TFL) deliverables; ensure completeness, accuracy, and regulatory/quality compliance.
- Review/approve statistical programming requirements (e.g., ADaM Mapping Specifications) and key study documents; communicate decisions/action items.
- Lead programming output development within the Study Management Team; attend SMT meetings; manage timelines and study programming dependencies.
- Provide quality management: perform QC checks, ensure correct execution order, validation documentation/folder locking/TMF compliance.
- Monitor quality/timeliness of deliverables; track activities in task management systems; manage data issues and Data Issue Log resolution prior to final release.
- Analyze vendor performance (KPI/KQI), participate in vendor governance, and address risks/bottlenecks.
- Ensure adequate resourcing, assign tasks, coach/mentor onboarding staff; hold analysis meetings with biostatisticians.
- Serve as primary point of contact with vendors and liaison with other functions; request locking/archiving of study folders.
Qualifications:
- Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.
Preferred:
- 2+ years leading studies in Virology, Oncology, or Inflammation; mature ADaM/TFL expertise.
- GCP/ICH and regulatory knowledge (quality oversight/assurance/risk management); strong data analysis and critical thinking.
- Strong non-compartmental PK programming experience; experience guiding TQT/cQT/PK/PD programs and cross-functional teams.
Benefits (if applicable): Company-sponsored medical, dental, vision, and life insurance plans.
Application: For Current Gilead Employees and Contractors, apply via the Internal Career Opportunities portal in Workday.