Manager, Statistical Programming

About the role

Gilead is seeking a Manager, Statistical Programming to join the Statistical Programming – Analysis Programming team. The role collaborates with internal colleagues and external vendors to produce high‑quality analysis datasets and statistical outputs for study reports and integrated summaries that support Gilead’s regulatory, scientific, and business objectives.

Responsibilities

• Work collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Generate or oversee the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries.
• Ensure programming and corresponding documentation are completed consistently with departmental procedures.
• Provide primary and secondary programming support as needed.
• Implement strategic initiatives.
• Apply analytical skills with advanced knowledge of statistics to multiple, time‑sensitive, and complex tasks.
• Maintain a thorough understanding of clinical trial design, reporting processes, and regulatory reporting requirements (including electronic submissions to FDA, PMDA, EMA, and other global agencies).
• Support integrated analysis activities for FDA and worldwide submissions, including post‑filing activities.
• Interact with other departments to define and produce user‑defined statistical reports (e.g., ad‑hoc requests).
• Resolve study‑related issues and conflicts within therapeutic projects.
• Create buy‑in, support, and negotiate timelines with stakeholders.

Basic Qualifications

• BS degree in Biostatistics/Computer Science or equivalent + 7+ years of experience in pharma/biotech
• OR MS degree in Biostatistics/Computer Science or equivalent + 3+ years of experience in pharma/biotech
• OR PhD degree in Biostatistics/Computer Science or equivalent + 2+ years of experience in pharma/biotech

Preferred Qualifications

• Degree in Biostatistics/Computer Science or equivalent with 7+ years of pharmaceutical/CRO experience
• Prior experience in oncology, hematology, virology, or inflammation
• Strong knowledge of submission processes
• Hands‑on experience in pivotal studies and regulatory submissions (NDA, BLA, MAA, etc.)
• In‑depth understanding of clinical and statistical programming processes and standards
• In‑depth knowledge of regulatory requirements relevant to statistical programming (e.g., GCP, ICH)
• Extensive experience with SAS programming, including development and use of SAS macros
• Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM)
• Proven experience in complex, fast‑turnaround programming activities
• Excellent interpersonal, communication, problem‑solving, and analytical skills

Pay

The salary range for this position is $146,540.00 – $189,640.00. Compensation may vary based on experience, qualifications, and geographic location. The role may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives, paid time off, and a benefits package.

Benefits

• Company‑sponsored medical, dental, vision, and life insurance plans
• Paid time off
• Discretionary annual bonus
• Stock‑based long‑term incentives (eligibility varies by role)
• Additional wellness and employee assistance programs