Vice President, Biometrics

Virbiotechnologyinc; San Francisco (CA); On-site; USD 325,000 - 365,000; Full time

Job summary

Vir Biotechnology, Inc. in San Francisco seeks a VP/Head of Biometrics to lead biostatistics, programming and clinical data management across phase I–III programs, guiding regulatory submissions and development strategy.

The ideal candidate has a PhD in Biostatistics or related field with 15+ years in biotech/pharma, proven leadership, budgeting and cross-functional collaboration; strong expertise in regulatory filings and innovative analytics. In-office 3 days/week at SF HQ.

Qualifications

• PhD in Biostatistics, Statistics, Mathematics or related field.
• 15+ years of biotechnology or pharmaceutical experience in immunology, infectious diseases, and/or oncology.
• Strong leadership, project, budget and people management experience.
• Extensive experience with drug development and regulatory filings.
• Experience with regulatory submissions (BLA/NDA/MAA).

Responsibilities

• Provide advanced statistical concepts across drug development programs.
• Lead and mentor teams in biostatistics, programming and clinical data functions.
• Develop group core competencies and foster continuous improvement.
• Lead statistical efforts to secure regulatory approvals.
• Partner with other functions to guide strategy, design and execution of development plans.
• Drive statistical deliverables for regulatory submissions and publications.
• Implement real-world data analytics to inform development.
• Manage departmental budget and resources.

Skills

Biostatistics

Statistical programming

Leadership

Education

PhD in Biostatistics

Job description

Vir Biotechnology, Inc. 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 PRO-XTEN® 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.

Vir Biotechnology has exclusive rights to the universal PRO-XTEN®masking platform for oncology and infectious disease. PRO-XTEN®is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

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 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

WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $325,000 to $365,000 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, 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.

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 any legally protected characteristics.

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 conduct 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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