VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.
Director, Biostatistics Role Overview:
The Director, Biostatistics will be responsible for ensuring statistical competencies are utilized in the best way to create value at Ironwood. The incumbent will actively contribute to strategic, methodological and operational clinical development activities across one or multiple therapeutic areas. They will provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts and manuscripts to ensure that statistical elements are in line with the overall product strategy.
Main Responsibilities:
* Contributes strategically to clinical development plans, regulatory strategies and life cycle planning to ensure that the company's clinical programs are optimally designed and executed.
* Provides statistical consultations and strategic inputs in terms of drug development for senior management and other staff within the company.
* Develops statistical analysis plans for studies, performs complicated statistical analyses and oversees the generation of tables, listings and figures for study reports and manuscripts.
* Reviews regulatory documents for accuracy and appropriateness of statistical interpretations and acts as statistical liaison to FDA/regulatory agencies.
* Demonstrates ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships.
Requirements:
* A PhD in Biostatistics/Statistics or related disciplines with 10 years of pharmaceutical experience including direct supervisory and management experience.
* Strong knowledge of statistical methodology in design and analysis.
* Experience with adaptive designs, Bayesian methods and advanced statistical modelling desirable.
* Familiarity with FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11 and EMA/CHMP regulations and guidelines.
* Fluent in spoken and written English.
Location: Basel
Reports to: Head of Data Science
Supervises: Statisticians at all levels (internally and externally)