Associate Director, Biostatistics

At Gilead, we’re creating a healthier world for all people. For more than 35years, 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.

As the Associate Director, Biostatistics, you will provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area. You will represent Biostatistics at study management and development teams for multiple studies or programs, collaborating closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, and Clinical Data Management to ensure high‑quality statistical planning, analysis, interpretation, and reporting.

• Lead as statistician for Phase1–3 clinical trials with overall statistical strategy and delivery
• Serve as biostatistics lead on clinical studies or other non‑molecule projects
• Represent Biostat on study management and development teams, providing strategic statistical leadership and collaborating closely with other Biostatistics team members and cross‑functional teams
• Provide statistical consultation on trial design, endpoints, and analysis methods, and author statistical analysis plans
• Oversee and lead all technical and operational statistical activities for a group of clinical trials
• Direct internal and external teams in defining, executing, and completing statistical activities for one or more molecules or marketed products
• Contribute strategic statistical leadership to cross‑functional clinical development planning and protocol development
• Advise internal and external partners on choice of statistical analysis strategies, measurement reliability, model identifiability, and interpretation and presentation of statistical results
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring to inform development decisions
• Use a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret historical and external data for clinical development insights
• Provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation
• Participate in or lead special projects that benefit multiple Biostatistics team members, such as innovative methodologies, processes, technology, and other tools
• Participate in the development and implementation of SOPs and related documentation
• Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs

• Bachelor’s Degree and 10years’ experience
• Master’s Degree and 8years’ experience
• PhD/PharmD and 5years’ experience

• Demonstrated ability to rapidly assimilate scientific and statistical information
• Demonstrated flexibility and adaptability to change, able to move between projects easily and provide support/expertise where needed
• Advanced knowledge of biomedical statistical analysis and independent design, implementation, and management of multiple statistical analysis strategies, plans, deliverables, and resources
• Advanced knowledge of biostatistics best practices and tools, and ability to apply them to improve overall results
• Strategic thinking in advising others on statistical requirements and opportunities to improve study or project outcomes
• Solid understanding of drug development phases and the nature of associated clinical trials across phases
• Knowledge of FDA, EMA regulations, ICH guidelines, GCP, and standard clinical procedures
• Strong written and verbal communication, collaboration, and organizational skills
• Experience in HBV and HIV programs is preferred
• Familiarity with innovative trial designs
• Proven effectiveness managing projects and teams

• Create inclusion: model inclusion, embed the value of diversity in team management
• Develop talent: understand employees’ skills, aspirations, and potential, coach on performance and growth
• Empower teams: connect the team to organizational goals,…