THE OPPORTUNITY:
Reporting to the Head of Biostatistics, the Director of Biostatistics provides technical leadership and biostatistical support to Clinical Development programs. You will be the statistical lead on one or more drug development projects and act as a statistical expert across all project studies, working collaboratively with clinicians, data managers, biostatisticians, and statistical programmers. You will use your project management and leadership skills in the planning, conduct, and analysis of clinical trials.
This is an onsite position in our San Francisco headquarters.
WHAT YOU'LL DO:
- As a biostatistics expert for VIR clinical programs, you will provide strategic input to optimize trial designs in late phase registrational studies.
- You will work with internal and external statistical programming team members on the planning and execution of statistical deliverables.
- Conduct statistical simulations to ensure robust and efficient statistical designs and address identified or potential statistical issues arising with studies.
- Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing other sections by applying statistical principles.
- Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables.
- Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses.
- Perform QC/QA of statistical deliverables including validation of main analysis results.
- Contribute to clinical study reports, including authoring of statistical methods and interpretation of study results.
- Accountable for assigned statistical activities to support IND/NDA/MAA or other regulatory submissions; provide review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents.
- Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs.
- Lead standardization and process improvement efforts for the Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatistics templates and standards.
- Represent VIR regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners.
- Support inspection readiness activities.
WHO YOU ARE AND WHAT YOU BRING:
- PhD in Biostatistics and 10+ years of relevant work experience, or M.S. in Biostatistics and 13+ years of relevant work experience.
- Hands-on experience in INDs, NDAs, MAAs, or other regulatory submissions.
- In-depth knowledge of statistical methods for clinical trials.
- Knowledge of FDA, EMA, and ICH regulations and guidelines.
- Proficient in statistical programming (SAS and R).
- Experience leading statistical efforts for multiple studies.
- Fluent in data standards, including SDTM and ADaM.
- Experience with outsourced statistical services provided by CROs.
WHO WE ARE AND WHAT WE OFFER:
The expected salary range for this position is $207,500 to $284,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all on-site employees.
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