Associate Director, Biostatistics

Responsibilities

• Serve as lead statistician for Phase 1–3 clinical trials with responsibility for overall statistical strategy and delivery
• Acts as biostatistics lead on clinical studies or other non-molecule projects
• Represent Biostats on study management teams and development teams, providing strategic statistical leadership, and collaborate closely with other Biostatistics team members and cross-functional team
• Provides statistical consultation on trial design, endpoints, analysis methods, and authors statistical analysis plans
• Overseas and lead all technical and operational statistical activities for a group of clinical trials
• Directs 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
• Where applicable, advises 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
• Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring to inform development decisions
• Uses 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
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation
• May participate in or lead special projects that can benefit multiple Biostatistics team members, such as innovative methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs

Basic Qualifications

Bachelor's Degree and 10 years’ experience OR Master's Degree and 8 years’ experience OR PhD and 2 years’ experience

Preferred Qualifications

• Demonstrated ability to rapidly assimilate scientific and statistical information
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
• Has advanced knowledge of biomedical statistical analysis, as evidenced by independence in designing, implementing and managing multiple statistical analysis strategies, plans deliverables and resource management
• Has advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results
• Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes
• Solid understanding of drug development phases and the nature of associated clinical trials across phases
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures
• Strong written and verbal communication, collaboration and organizational skills
• Experience in Virology is preferred
• Familiar with innovative trial designs
• Proven effectiveness managing projects and teams