Associate Director, Biostatistics

About This Role

This Associate Director role provides strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area. The successful candidate will represent Biostatistics at study management teams and development teams for multiple studies or programs, collaborating closely with various cross-functional teams to ensure high-quality statistical planning, analysis, interpretation, and reporting. This includes providing statistical strategic input into study design, clinical development plans, sample size determination, protocol development, statistical analysis plan (SAP) authoring, TFLs and clinical study report (CSR) review, and biostatistical input into scientific publications, presentations, and regulatory requests. In addition to clinical trials, the role may lead or contribute to non-molecule based activities such as department strategic initiatives or working groups.

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 Biostatistics on study management teams and development teams, providing strategic statistical leadership, and collaborate closely with other Biostatistics team members and cross-functional teams
• 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
• Direct internal and external teams in the definition, execution and completion of 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 as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, 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 to derive useful information for clinical development
• Provide biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation
• Participate in or lead special projects that can benefit multiple Biostatistics team members, such as innovative methodologies, processes, technology and other tools
• Participate in the development and / or implementation of SOPs and related documentation
• Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs