Director, Biostatistics

Gilead Sciences, Inc.•Foster City, CA

70d•Onsite

About The Position

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. Job Description Are you passionate about leveraging your biostatistical expertise to make a meaningful difference for patients? Are you interested in an exciting opportunity to immediately gain more direct experience with regulatory submissions? Join our Biostatistics team and take on a pivotal role in shaping our on-going regulatory submissions. If you have a solid background in clinical trial design and analysis and are eager to tackle challenges that drive scientific and regulatory advancements, we want you to be part of our team! Biostatisticians at Gilead work collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives. The Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead. He/she will support Virology drug development, working collaboratively for the development plans, regulatory interactions, and commercial evaluation of a Gilead Virology compound in one or more indications. This is a site based role located at our global headquarters in Foster City, CA.

Requirements

PhD with 8+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
Master's Degree with 10+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
Bachelor's Degree with 12+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)

Nice To Haves

Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred)
Extensive hands-on experience in drug development including design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation
Effective verbal and written communication skills with the ability to convey complex concepts in clear, concise, and accessible language
Strong collaboration and interpersonal skills with demonstrated success in fostering effective relationships and working seamlessly within diverse cross-functional team
Adept at analyzing challenges from a holistic, cross-functional viewpoint to align with broader organizational or project goals
Anticipates obstacles and understands stakeholder needs to proactively develop and implement practical and effective solutions
Demonstrated ability to assemble and lead high-performing teams, providing clear direction and fostering a shared vision for success

Responsibilities

Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support.
Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance
Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources
Leads two or more components of departmental strategic initiatives

Benefits

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.

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