Role Summary
Director, Biostatistics, based at Gilead’s global headquarters in Foster City, CA. The role leads the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products, supporting development plans, regulatory interactions, and the commercial evaluation of Virology compounds across one or more indications. The position provides statistical leadership for Virology clinical trials, collaborating across multifunctional teams to meet project deliverables and regulatory objectives.
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
- Work 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
- Direct internal and external teams across multifunctional project or functional areas, lead initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, work with management and Human Resources to satisfy short-term staffing needs, defend statistical aspects with regulatory agencies, develop staff capabilities, and recognize/reward desired performance
- 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
- Lead two or more components of departmental strategic initiatives
Qualifications
- Basic: PhD with 8+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
- Basic: Master’s Degree with 10+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
- Basic: Bachelor’s Degree with 12+ years of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
- Preferred: Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred)
- 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
- Preferred: Effective verbal and written communication skills with the ability to convey complex concepts in clear, concise, and accessible language
- Preferred: Strong collaboration and interpersonal skills with demonstrated success in fostering effective relationships and working seamlessly within diverse cross-functional team
- Preferred: Adept at analyzing challenges from a holistic, cross-functional viewpoint to align with broader organizational or project goals
- Preferred: Anticipates obstacles and understands stakeholder needs to proactively develop and implement practical and effective solutions
- Preferred: Demonstrated ability to assemble and lead high-performing teams, providing clear direction and fostering a shared vision for success
Education
- PhD in a statistical field or related discipline (required for Basic qualification)
- Master’s Degree in a statistical field or related discipline (alternate Basic qualification)
- Bachelor’s Degree in a statistical field or related discipline (alternate Basic qualification)