- Doctoral Degree
- Master's Degree
- Statistical Software
- Management Experience
- Clinical Trials
The Director of Biostatistics will independently perform highly scientific statistical functions in support of the company’s Global Medicines Development and Affairs (GMDA) area on new and complex issues. He/She will complete work in a resourceful, self-sufficient manner and create 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. He/she should possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
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 the Peer Protocol Review Committee (PPRC) or other 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) 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 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 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