Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio .
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
The Associate Director, Biostatistics will perform highly scientific statistical functions in support of the company's clinical development programs with minimal guidance. They will complete assigned work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. In addition, the Associate Director of Biostatistics is capable of independent strategic and technical contributions. Skill in project and personnel oversight may also be required. They should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Is responsible for all scientific and operational statistical analyses for multiple clinical trials, observational studies, or real world data (RWD) investigations. May include presentation to internal senior review boards, such as protocol review.
- Possesses an advanced understanding of modern drug discovery and development processes.
- Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to team members.
- Authors Statistical Analysis Plans (SAPs) and communicates key study results. Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
- Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.
- Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review.
- Contributes to external interactions with regulators, payers, review boards, etc.
- Leads implementation of innovative designs and analysis methods at the study or project level and participates in Biostatistics team discussions of studies assigned to others
QUALIFICATIONS AND EXPERIENCE
- Ph.D. in Biostatistics and 6 years of relevant work experience, or
- B.S/M.S. in Biostatistics and 9+ years of relevant work experience
- Competence with SAS and R statistical software
- Demonstrated understanding of statistical methods used in drug development
- Ability to show critical thinking with logical problem-solving
- Collaborates well with non-statisticians
- NDA/MAA experience and/or direct dealings with USA/European regulators
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 lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
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.