Associate Director, Biostatistics

About the role

As the Associate Director, Biostatistics, you will provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area. You will serve as the lead statistician for Phase 1-3 clinical trials, representing Biostatistics on study management teams and development teams, collaborating closely with other Biostatistics team members and cross-functional teams.

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, and collaborate closely with other Biostatistics team members and cross-functional team
• Provide statistical consultation on trial design, endpoints, analysis methods, and authors statistical analysis plans
• Contribute strategic statistical leadership to cross-functional clinical development planning and protocol development
• Advise internal and external partners on statistical analysis strategies, reliability of measurements, 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 tools, and may also participate in the development and / or implementation of SOPs and related documentation

Requirements

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. Advanced knowledge of biomedical statistical analysis, as evidenced by independence in designing, implementing and managing multiple statistical analysis strategies, plans deliverables and resource management. Advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results. 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 HBV and HIV programs is preferred. Familiar with innovative trial designs. Proven effectiveness managing projects and teams.

Qualifications

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

Skills

Strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes. Ability to adapt to changing priorities and deadlines. Strong analytical and problem-solving skills. Excellent communication and collaboration skills. Proficiency in statistical software and tools. Knowledge of clinical trial design and methodology. Familiarity with regulatory requirements and guidelines.

Benefits

The salary range for this position is Bay Area: $195,670.00 - $253,220.00. Other US locations: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit here.

Pay

The salary range for this position is Bay Area: $195,670.00 - $253,220.00. Other US locations: $177,905.00 - $230,230.00.

Schedule

N/A