Biostatistics Leader
3 weeks ago
The Associate Director, Real World Statistics will lead and perform sophisticated scientific statistical analyses in support of Vertex's post-marketing areas, including Global Medicines Development and Affairs, and Commercial and Strategic Management. The incumbent will serve a lead role on assigned projects, including clinical trials, real-world observational studies, market access, and reimbursement activities, with minimal guidance and mentoring.
Key Responsibilities- Responsible for all scientific and operational statistical work for multiple clinical trials and observational studies, or real-world data investigations.
- May include management, oversight, and strategic directions of one or more projects or major components of a project.
- Mentors junior personnel, possibly including one or more direct reports.
- May include presentation to the Peer Protocol Review Committee or other internal senior review boards.
- Possesses an advanced and in-depth understanding of modern drug discovery, development, and post-marketing processes.
- Represents Real World Statistics 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 study Statistical Analysis Plans, including table, figure, and listing shells, and develops study documents to facilitate the review, summary, and dissemination of key study data/results.
- Collaborates with statistical programming and other functions to ensure timely delivery of high-quality results.
- Ph.D. in Biostatistics or related fields and 7 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 advanced statistical methods used in drug development.
- Ability to show critical thinking with logical problem-solving.
- Excellent written and verbal communication skills.
- Excels in a team environment and collaborates well with non-statisticians.
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Clinical Development Director
4 weeks ago
Étreux, Hauts-de-France, United States CK Group Full timeDirector/Snr Director, Clinical Development, Melanoma The ideal candidate will be a medical professional with a specialization in oncology, preferably board-certified, and a deep understanding of the solid tumor landscape. They should have a proven track record of leading and facilitating late-stage clinical development strategic planning and be accountable...