Senior Director, Biostatistics

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

The Opportunity

Vir Biotechnology is looking for a technical leader for our Senior Director, Biostatistics opening. In this role you will be at the forefront of leading the technical direction of our clinical development programs across one or more assets, spearheading transformative drug development projects that have the potential to change lives globally. This role is not just about statistics; it's about leadership, strategic drug development, innovative methodology in study design and execution, and making a tangible impact.

You will be responsible for developing and executing our biostatistics strategy, directly impacting the overall success of our programs. In this role you will provide strategic input into clinical development programs, partner with cross-functional leads to drive innovative study designs, aligning the clinical development plan (CDP) with Vir Bio's portfolio strategy, and effectively managing resources to execute the CDP and produce quality deliverables.

This role is based in San Francisco and requires 4 days a week onsite.

What You'll Do

• As a biostatistics expert, you will provide strategic input to optimize trial designs and the clinical development plans for all assigned molecules
• Lead biostatistics efforts for clinical protocol development, including contributing to study design methodology, authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
• You will work with internal and external statistical programming team members on the planning and execution of statistical deliverables
• Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve these goals in creative and effective ways
• Conduct statistical simulations to ensure robust and efficient statistical designs and address identified or potential statistical issues arising with studies
• 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
• Provide strategic input and guidance to ensure the high quality of Regulatory Authority documents, including clinical protocols, statistical analysis plans, study reports, briefing books, submissions, and safety reports.
• Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
• You will be the lead representative 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 15+ years of relevant work experience, M.S. in Biostatistics and 18+ years of relevant work experience
• Experience in strategic drug development and innovative leadership
• Experience in matrix organization, collaboration with cross functional key stakeholders, and ability to influence
• Experience leading complex drug development programs and statistical efforts for multiple studies
• Ability to translate strategy into implementation
• 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)
• Fluent in data standards, including SDTM and ADaM

Who We Are And What We Offer

The expected salary range for this position is $235,000 to $329,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Vir Biotechnology'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 Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, childcare reimbursement, education reimbursement, 401K match and lunch each day in the office.