THE OPPORTUNITY
Vir Biotechnology is seeking a Vice President/Head of Biometrics to lead the biostatistics, statistical programming and clinical data management functions. In this role, you will lead the strategy, development and execution of the clinical pipeline, including phase I-III providing strategic guidance to ensure high quality preparation of Regulatory Authority documents and other study-relevant materials as needed. You will work across a matrixed environment with non-clinical and clinical teams to ensure fully harmonized and integrated development strategies.
This role is located at Vir Bio’s San Francisco headquarters with an expectation of 3 days per week in the office.
WHAT YOU'LL DO
- Provide advanced and innovative statistical concepts across Vir Bio’s drug development programs, clinical to commercialization
- Lead, mentor and develop high performing teams in biostatistics, programming and clinical data functions
- Develop core competencies of the group, foster a culture of continuous improvement and innovation within the team
- Lead statistical efforts to secure regulatory approvals
- Serve as the strategic partner working closely with other relevant functions in providing statistical input into strategy, design and execution of clinical development plans and trial designs
- Drive biostatistical facets of all major deliverables (regulatory submissions, original articles, abstracts) and presentation materials
- Formulate clinical data science roadmap and implement the appropriate use of real-world data (RWD) analytics to inform clinical development across clinical programs
- Manage departmental budget, resource allocation
WHO YOU ARE AND WHAT YOU BRING
- PhD in Biostatistics, Statistics, Mathematics or related field is required
- Minimum 15+ years of biotechnology or pharmaceutical experience in immunology, infectious diseases, and/or oncology
- Passion for innovation and creativity with new techniques and ideas in biometrics
- Experience demonstrating successful leadership, project, budget and people management
- Demonstrated experience across all phases of drug development, with a strong understanding of the interfaces and interdependencies between clinical development and other functions, including end-to-end clinical development and regulatory filings
- Extensive experience with BLA/NDA/MAA submissions, as well as successful negotiation with health authorities is required
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