Analysis Oversight Statistical Programming Lead- Manager

Job Overview

Clinical Data Science (CDS) is a business unit within Development whose mission is to achieve regulatory approval and successful marketing of new therapies through a reproducible, transparent, efficient, and validated approach to study design, data acquisition, analysis, and interpretation. The Analysis Oversight Statistical Programming (AOSP) Lead works closely with the Study Management Team (SMT) to determine statistical programming requirements, understand study milestones, and deliver high‑quality statistical programming outputs that meet regulatory and quality standards.

• Exhibit strong statistical and programming knowledge and expertise to influence key decisions on statistical programming outputs.
• Attend SMT meetings, providing functional input on programming related activities and potential risks.
• Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
• Communicate SMT decisions, discussions, and action items to statistical programmers.
• Review and approve key study documents and help statistical programmers understand critical study documents.
• Review statistical programming timelines and negotiate with study team if needed.
• Participate in internal and external audits and identify areas of opportunity to refine and simplify procedural steps.
• Analyze vendor performance through assessment of Key Performance and Quality Indicators (KPI, KQI), metrics, and results.
• Participate in vendor governance discussions to address performance related risks and/or concerns.
• Ensure adequate statistical programming resourcing for study milestones.
• Assign tasks to statistical programmers based on experience and ability.
• Closely monitor and track study statistical programming activities within task management system.
• Maintain regular communications on study statistical programming milestone activities with appropriate study team members and stakeholders.
• Influence and support data and submission standards, templates, etc.
• Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards.
• Surface the need for new or updated standards to improve efficiency and uniformity across TA or indication level objects.
• Provide prioritization decisions and coaching to fellow onboarding staff as needed to advance their knowledge on Gilead processes and statistical programs & methods.
• Ensure the programming team identifies data issues and enters them into the Data Issue Log, and that all issues are resolved prior to final production release.
• Hold analysis team meetings with Biostatisticians.
• Serve as the point‑of‑contact with vendors and liaise with other functions.
• Request the locking and archiving of study folders.

• Bachelor’s Degree and seven years of experience OR Master’s Degree and five years of experience.
• Minimum two years leading studies in Virology, Oncology, or Inflammation therapeutic area.
• Mature statistical knowledge and expertise in development of ADaM and TFLs and dependent tasks/activities.
• Proven track record in delivering high‑quality statistical programming datasets and outputs.
• Ability to collaborate and work effectively with global team members and build strong relationships.
• Expertise working in global teams across various time‑zones to achieve clinical trial milestones.
• Up‑to‑date and deep knowledge of GCP, ICH guidelines, and regulatory requirements, specifically related to quality oversight, quality assurance, and risk management.
• Ability to problem‑solve using data‑driven approaches to determine the best path forward.
• Excellent customer‑focus with proven track‑record in building relationships through communication and writing skills.
• Superior skills in coaching and mentoring staff of varying skillsets and respectful of cultural differences especially communication styles.
• Results‑oriented and able to work closely with others through collaboration to resolve challenges, bottlenecks, or risks.
• Ability to motivate large diverse teams to achieve a common set of goals.
• Strong experience in data analysis and demonstrated critical thinking skills.
• Strong programming experience in…