Associate Director, Biostatistics
About The Position
The Associate Director, Biostatistics is responsible for providing the statistical expertise for products within a therapeutic area, including response to statistical issues arising in regulatory, commercial, worldwide medical or other legal settings, and may include addressing issues from external development partners and internal cross-functional project teams. He/She builds and maintains strong collaboration with collaborators from different disciplines across the organization to identify and meet their needs for statistical support. He/She also contributes to the long-term growth strategy of the department. This person provides mentorship to junior biostatisticians in the department. He/She ensures that standard procedures are followed within projects. This person will act as CDT statistician and will have limited participation in Asset Team Meetings. May act as SMT statistician for complex Phase 3 studies. Will also have increased exposure to KOL collaborations/meetings. Successful candidate will: Represent Biostatistics on CDT/Asset teams and provides professional statistical support to clinical development team. Ensure timeliness and high quality of Biostatistics deliverables. Able to handle requests from regulatory agencies, health authorities, across multiple drug programs, often under tight timelines. Able to make decisions at CDT level across a variety of studies with minimal input from line or project manager. Able to work with others to identify and resolve areas of concerns. Takes initiative to communicate issues within or across multiple project team(s). Able to handle large volume of highly complex tasks with minimal supervision. Will be the primary contact for management, CDT/Asset teams, CROs, KOL's in respect to statistical consultation for products within a TA. Interacts with team members across functional areas and multiple studies. Represents the organization in meetings or on teams. Lead organization-wide led initiatives e.g. Quality, standardization etc.
Requirements
- Broad and thorough understanding of statistical principles and clinical trial methodology, and the ability to practice and implement them.
- Ability to develop innovative/creative statistical/technical solutions to complex problems.
Responsibilities
- Represent Biostatistics on CDT/Asset teams and provides professional statistical support to clinical development team.
- Ensure timeliness and high quality of Biostatistics deliverables.
- Able to handle requests from regulatory agencies, health authorities, across multiple drug programs, often under tight timelines.
- Able to make decisions at CDT level across a variety of studies with minimal input from line or project manager.
- Able to work with others to identify and resolve areas of concerns.
- Takes initiative to communicate issues within or across multiple project team(s).
- Able to handle large volume of highly complex tasks with minimal supervision.
- Will be the primary contact for management, CDT/Asset teams, CROs, KOL's in respect to statistical consultation for products within a TA.
- Interacts with team members across functional areas and multiple studies.
- Represents the organization in meetings or on teams.
- Lead organization-wide led initiatives e.g. Quality, standardization etc.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
