United States- REMOTE /
Translational Clinical Development – Biometrics and Statistics /
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 Director of Biostatistics will independently perform highly scientific statistical functions in support of the Vir Biotechnology’s Translational and Clinical Department area on new and sophisticated issues. They will complete work in a resourceful, self-sufficient manner and build alternative approaches to achieve desired results if needed. In addition, the Director provides independent strategic and technical contributions. Skill in project and personnel oversight is also required. The Director should possess an excellent knowledge of related subject areas while performing Biostatistics activities with a drug developer mentality.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Is responsible for the management, oversight, operation, and direction of one or more projects from a biostatistics point of view. Oversight may include multiple clinical trials, observational studies, or real world data (RWD) investigations. Also includes presentation to VIR internal senior review boards.
- Mentors junior personnel, possibly including one or more direct reports. Accountable for assigned projects and the performance of all Biostatistics staff working on the project(s). Responsible for effective team operation and cross-functional collaboration.
- Possesses an advanced understanding of modern drug discovery and development processes.
- Effectively communicates in a team setting utilizing strong interpersonal skills. Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to team members.
- Develops technical leadership and guides project teams to more meaningful and/or productive ends. Sets the technical and scientific directions of the project(s).
- 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) 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 external interactions with regulators, payers, review boards, etc.
- Authors or co-authors methodological or study-related publications and posters.
- Leads implementation of innovative designs and analysis methods at the study or project level.
- Contributes to departmental working group efforts on various technical and operational issues.
- The Director must have NDA/MAA experience and direct dealings with USA/European regulators.
QUALIFICATIONS AND EXPERIENCE:
- Ph.D. in Biostatistics and 10 years of relevant work experience, or M.S. in Biostatistics and 13 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
- Experience in people management
- Excels in a team environment
- Collaborates well with non-statisticians
This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US. If you move forward in the hiring process, VIR recruiters will discuss options with you.
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, 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.