Senior Director, Biostatistics-Oncology Program lead

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 infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections 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 passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results.

THE OPPORTUNITY

Vir Biotechnology is looking for a highly technical and strategic leader for our Senior Director, Biostatistics opening. In this role you will be at the forefront of leading the technical and strategic direction of our clinical development programs across all Oncology 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 in oncology clinical research and development.

You will be responsible for developing and executing our biostatistics strategy, directly impacting the overall success of our oncology 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 is on onsite role at our San Francisco headquarters (4 days a week) reporting directly to our head of Biometrics.
WHAT YOU'LL DO

• As a biostatistics expert for clinical oncology programs, you will provide strategic input to optimize trial designs and the clinical development plans for all oncology molecules
• Collaborating with other biometrics leaders, establish vision and direction for the development and implementation of oncology TA standards and practices and oversight of process improvement initiatives
• Lead biostatistics efforts in oncology 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 multiple complex oncology 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

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WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $262,000 to $329,000. 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 benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch each day in the office.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Vir Biotechnology is an equal opportunity employer. All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology, participates in E-Verify.

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