Associate Director Statistical Programming Jobs in California

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Job Description

Position Summary

Provides strategic, operational, and handson (playercoach) leadership for compoundlevel 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, highquality, and inspectionready delivery while driving modernization through AIenabled 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 endtoend programming strategy and execution for compoundlevel 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 handson 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 lessexperienced colleagues and contribute to development of standards, tools, and templates.
• Drive adoption of AIenabled 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 problemsolving skills in complex situations; ability to prioritize critical issues.
• Demonstrated ability to work crossfunctionally and influence decisionmaking.

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 crossfunctional project management experience, including managing project teams.
• Significant line management experience with a proven record of hiring and developing highperforming talent.
• Extensive experience with SAS; experience with R and/or Python preferred.
• Demonstrated leadership in change management and standards adoption.

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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