The Associate 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 serve biostats lead role on assigned projects including Phase 3b/4 clinical studies, real world evidence (RWE) studies, market access and reimbursement, and other post-approval and medical affairs activities.
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 Associate 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 Associate 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.
- Serve as biostats lead for Phase 3b/4 clinical studies, real world observational (RWE) studies, and a variety of post-approval and medical affairs activities including new drug's market access and reimbursement, value dossier development, health economic and cost-effectiveness analyses, and other relevant adhoc request support.
Effectively collaborate with multiple stakeholders from Clinical Development, Medical Affairs, HEOR, Market Access, and RWE teams. 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.
- Mentors junior personnel, possibly including one or more direct reports.
- Possesses an advanced understanding of modern drug discovery and development processes.
- 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 Associate Director must have NDA/MAA experience and direct dealings with USA/European regulators.
This job has expired.
- Ph.D. in Biostatistics and 7 years of relevant work experience, or
- M.S. in Biostatistics and 10 years of relevant work experience