Director Biostatistics - late-phase Virology (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

 

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

The Director, Biostatistics will provide statistical leadership for late-phase Virology clinical development programs, supporting the design, analysis, interpretation, and communication of clinical trial results. As a potential Biostatistics Program Lead, this individual will collaborate closely with cross-functional teams to ensure the delivery of high-quality statistical contributions that support clinical development, regulatory submissions, and evidence generation. The successful candidate will combine strong technical expertise, sound scientific judgment, and effective communication skills to help advance innovative therapies for patients.

Key Responsibilities

• Provide statistical leadership for late-phase Virology clinical development programs, contributing to study design, analysis planning, data interpretation, and evidence generation to support development and regulatory objectives.
• Opportunity to serve as the Biostatistics Program Lead for Virology programs or major studies, representing the Biostatistics function on cross-functional teams and supporting interactions with Health Authorities as needed.
• Partner effectively with Statistical Programming, Clinical Development, Data Management, Clinical Operations, Global Patient Safety, Regulatory Affairs, Medical Writing, and Project Management to ensure timely delivery of high-quality analyses, regulatory submissions, and clinical study reports.
• Apply statistical expertise and regulatory knowledge to support study design, protocol development, statistical analyses, interpretation of clinical trial results, and preparation of regulatory documentation.
• Provide leadership for statistical activities across assigned clinical studies, ensuring high-quality study design, analysis planning, data review, and regulatory documentation through collaboration with internal teams, external partners, and CROs.

Basic Qualifications:

• 12+ Years with bachelor's degree
• 10+ Years with master's degree
• 8 years with PhD

Preferred Qualifications:

• Demonstrated hands-on experience in clinical drug development, including design, analysis, and interpretation of late-phase clinical trials and support of regulatory submissions.
• Strong expertise in biostatistics and clinical trial methodology, with proficiency in industry-standard statistical software and application of appropriate statistical methods to support study objectives and decision-making.
• Good understanding of the biopharmaceutical development process and regulatory environment, with the ability to integrate scientific and regulatory considerations into statistical recommendations.
• Proven ability to work effectively in cross-functional teams and communicate statistical concepts to a variety of stakeholders, including clinicians, regulatory colleagues, and senior management.
• Experience leading statistical activities for clinical development programs or major studies, managing multiple priorities, and delivering high-quality results within timelines.

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. 

The salary range for this position is:

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*.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact View email address on apply.placed-app.com for assistance.

For more information about equal employment opportunity protections, please view the  'Know Your Rights' poster.

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