Sr. Director, Biostatistics
|Department:||Clinical Affairs Administration|
|# of Openings:||1|
Functional area: Biostatistics
The Senior Director, Biostatistics leads the Biostatistics function within the Data Science Department (covering Biostatistics, Clinical Data Management, Statistical Programming, Study Endpoints, & HEOR) and manages staff within Biostatistics. The Director is charged with oversight of the statistical aspects of Ironwood product development programs and cross-functional leadership of corporate initiatives and R&D responsibilities. In particular, the design, analysis, and reporting of individual clinical trials and regulatory submissions (e.g., Summary of Clinical Efficacy) are the key responsibilities of the Biostatistics function. In addition, the Biostatistics function works collaboratively with adjacent Ironwood functions in the design and implementation of eCRFs, ePRO diaries, risk-based monitoring plans, regulatory meeting packages, publication plans, etc. Externally, Biostatistics provides input and approval for partner-resourced clinical trials including: scoping the trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers. Lastly, there are diverse opportunities to lend statistical expertise to projects arising in Discovery, Drug Safety, Marketing, Corporate Development, and other areas beyond clinical development.
As an individual contributor, the Senior Director will also provide timely and efficient management of individual clinical trial conduct, analysis, and reporting (Phases I to IV); lead the collaborative process for selecting sample sizes and statistical methods; produce key results and sensitivity analyses leading to the authoring of clinical study reports, especially the inferential conclusions; manage external vendors providing analysis and reporting; prepare material for and present at Investigator Meetings; coauthor primary and secondary manuscripts of clinical trial results. Further, the Senior Director will provide strategic oversight of product development programs and contribute to the governance of the R&D Portfolio as both a presenter and member of the senior R&D management.
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