The Director of Biostatistics will perform highly scientific statistical functions in support of the company’s Global Medicines Development and Affairs (GMDA) area with minimal guidance and mentoring on new and complex issues. He/She will complete assigned work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed.
In addition, the Director is capable of independent strategic and technical contributions. Skill in project and personnel oversight may also be required. He/she should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
The Director of Biostatistics:
- Is responsible for all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations. May include management, oversight, and strategic directions of a project or major components of a project.
- Also may include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
Mentors junior personnel, possibly including one or more direct reports.
- 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.
- 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.
- 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 and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
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.
- Ph.D. in Biostatistics and 10 years of relevant work experience, or
M.S. in Biostatistics and 10 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
- Excels in a team environment
- Collaborates well with non-statisticians
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition.