Director, Safety Statistical Programming

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Position Summary

Provides strategic, operational, and hands‑on (player‑coach) leadership for compound‑level safety statistical programming and aggregate safety reporting deliverables, including DSUR, PSUR/PBRER, Risk Management Plan (RMP), IBRSI, and support for broader safety surveillance and safety analytics. Leads teams and oversees vendors to ensure timely, high‑quality, and inspection‑ready delivery while driving modernization through AI‑enabled and automated programming approaches.

This is a site-based role in Foster City, CA. We do offer two days (Monday, Friday) as optional work from home with our core collaboration days in the office; Tues, Wed, Thurs. Remote work is not available for this position currently.

Key Responsibilities

• Lead end‑to‑end programming strategy and execution for compound‑level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI).
• Provide strategic oversight of roles, responsibilities, and build steps for aggregate safety programming delivery.
• Serve as escalation point for complex pooled/cumulative safety analyses and urgent ad hoc safety requests.
• Maintain hands‑on engagement to ensure technical correctness, reproducibility, and delivery reliability for critical outputs.
• Ensure consistent processes, folder structures, and operational readiness for safety programming deliverables.
• Own and continuously improve quality management practices, including definition and monitoring of KPIs.
• Provide vendor/FSP oversight and governance, ensuring training readiness, documented expectations, and appropriate QC.
• Lead, mentor, and develop Safety Statistical Programming staff; oversee less‑experienced colleagues and contribute to development of standards, tools, and templates.
• Drive adoption of AI‑enabled and automated programming approaches to improve efficiency, consistency, and quality.

Capabilities & Requirements

• Excellent written and verbal communication; strong influencing and negotiation skills.
• Deep knowledge of drug development, regulatory expectations, and industry standards for safety programming and reporting.
• Proven ability to lead people leaders, delegate effectively, coach performance, and support career development.
• Strong judgment and problem‑solving skills in complex situations; ability to prioritize critical issues.
• Demonstrated ability to work cross‑functionally and influence decision‑making.

Education & Experience

• Bachelor’s degree or higher in Biostatistics, Computer Science, or related field with 12+ years of relevant industry experience.
• 6+ years of leadership or cross‑functional project management experience, including managing project teams.
• Significant line management experience with a proven record of hiring and developing high‑performing talent.
• Extensive experience with SAS®; experience with R and/or Python preferred.
• Demonstrated leadership in change management and standards adoption.

 

The salary range for this position is: $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

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