Overview:
In this role you will provide strategic and operational biostatistics leadership for Virology clinical development programs, guiding study design, analysis, and reporting across multiple trials. You will collaborate with cross-functional teams to ensure high-quality statistical planning and regulatory compliance. The position offers opportunities to influence development decisions and contribute to scientific publications and regulatory submissions. You will lead or contribute to department initiatives and help advance Gilead’s mission to improve global patient outcomes. Compensation / Benefits discretionary annual bonus discretionary stock-based long-term incentives paid time off medical, dental, vision, and life insurance plans benefits package information available inclusive work environment
Responsibilities:
Serve as lead statistician for Phase 1–3 clinical trials with responsibility for overall statistical strategy and delivery Act as biostatistics lead on clinical studies or other non-molecule projects Represent Biostat on study management teams and development teams, providing strategic statistical leadership Provide statistical consultation on trial design, endpoints, analysis methods, and author statistical analysis plans Oversee and lead all technical and operational statistical activities for a group of clinical trials Contribute strategic statistical leadership to cross-functional clinical development planning and protocol development Advise on statistical analysis strategies, measurements, and interpretation of results Review and analyze safety reporting, biomarker analyses and other trial monitoring aspects to inform development decisions Use advanced statistical software and methods to analyze historical and external data for clinical development Provide biostatistical input into publications, presentations, and regulatory documentation Participate in or lead special projects to improve methodologies, processes, or tools and contribute to SOPs Adhere to regulatory requirements, industry standards, and Gilead SOPs
Key requirements:
Bachelor's Degree and 10 years’ experience OR Master’s Degree and 8 years’ experience OR PhD/PharmD and 5 years’ experience Demonstrated ability to assimilate scientific and statistical information quickly Flexibility and adaptability to change and cross-project support Advanced knowledge of biomedical statistical analysis with independence in designing and managing multiple strategies Advanced knowledge of biostatistics best practices and tools Strategic thinking in advising on statistical requirements and opportunities to improve outcomes Solid understanding of drug development phases and clinical trial types across phases Knowledge of FDA and 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 Familiar with innovative trial designs Proven track record of project and team management People Leader Accountabilities and leadership能力 collaboration communication adaptability biostatistics analysis and study design statistical consultation and SAP authoring protocol development and TFLs/CSR reviews