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. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other 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:
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 role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
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 of 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 Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics 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
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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.
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 (“Vir”) is an equal opportunity employer. All employment decisions at Vir 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 also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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, Inc., participates in E-Verify.
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