Analysis Oversight Statistical Programming Lead- Manager

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 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. #J-18808-Ljbffr Scorpion Therapeutics