Sr. Director, Biostatistics
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It’s an exciting time for Ironwood. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.” This new way of doing business will enhance our agility and innovation, and empower our teams to make a bigger impact on our patients and on our industry.
The new Ironwood will focus on accelerating the growth of our marketed product Linzess® (linaclotide) and advancing the development of our innovative pipeline of treatments for GI diseases and abdominal pain. Following completion of the separation, theDirector, IT, Data Management position will be part of the new Ironwood. The role will remain as described here.
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 clinical development programs and provides cross-functional leadership of R&D initiatives and Data Science 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 Corporate Development, Drug Safety, Pharmaceutical Development, and other areas beyond clinical development.
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