Director, Biostatistics

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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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.

Key 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

Basic Qualifications:

• PhD with 8 years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)

• Masters Degree with 10 years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)

• Bachelors Degree with 12 years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)

Preferred Qualifications:

• 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

For additional benefits information visit:

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

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