Associate Director, Biostatistics- Virology
Gilead Sciences
Summary
As the Associate Director, Biostatistics, you will provide strategic and operational statistical input for clinical development programs within the Virology Therapeutic Area. You will represent Biostatistics at study management team and development team for multiple studies, collaborate closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, Clinical Data Management to ensure high-quality statistical planning, analysis, interpretation, and reporting. This may include, but is not limited to, providing statistical strategic input into study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs and CSR review, and providing biostatistical input into scientific publications and presentations, and regulatory requests. In addition to clinical trials, you may lead or contribute to other activities that are non-molecule based, such as department strategic initiatives or working groups. This position is an on site/ hybrid role requiring the candidate to be on site 3 days a week.
Job description
Key Responsibilities
- Serve as lead statistician for Phase 1–3 clinical trials with responsibility for overall statistical strategy and delivery
- Represent Biostatistics on study management teams and development teams, providing strategic statistical input, 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
- 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.
- 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.
- Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.
People Leader Accountabilities
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Requirements
- 10+ Years of relevant experience with BS/BA OR 8+ Years of relevant experience with MS/MA or MBA OR 5+ years of relevant experience with PhD
- PhD is strongly preferred for this position
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Annual Bonus
- Stock-based Long-term Incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.