Director, Safety Statistical Programming
About The Position
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.
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.
- 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.
Nice To Haves
- experience with R and/or Python preferred
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.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
