Associate Director Biostatistician

pIronwood Pharmaceuticals is 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. We are pioneers in the development of LINZESS® (linaclotide), the U.
S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next‑generation, long‑acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure. Building upon our history of GI innovation, we keep patients at the heart of our RD and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. /ppFounded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland /pPurpose/Summary:pThe Associate Director, Biostatistics, is responsible for providing strategic, methodological, and operational statistical leadership to create value at Ironwood. The role partners closely with cross‑functional teams to shape clinical development strategies and contributes to the design, analysis, interpretation, and communication of clinical data through development plans, study protocols, statistical analysis plans, clinical study reports, regulatory submissions, publications, and business development activities. The Associate Director ensures scientific rigor, data‑driven decision‑making, and alignment with overall product development objectives. The position is a hybrid position located onsite at our office in Basel, Switzerland. /ppAdditional responsibilities include maintaining expertise in applicable regulatory guidance and industry best practices and promoting compliance through SOP development and training; br / br / leading the evaluation and implementation of innovative statistical methodology to support drug development; br / br / and overseeing externalvendors and CRO to ensure high quality, timely and compliant deliverables . /pEssential Functions:ulliServes as the lead statistician and primary statistical representative for assigned clinical studies, providing statistical leadership for study design, protocol development, sample size determination, power calculations for complex study designs, generation of randomization schedule, data sources, statistical analysis plans, clinical study reports, and regulatory interactions; br / br / /liliProvides statistical inputs to clinical development plans, regulatory strategies, and life cycle planning ; br / br / /liliProvides statistical consultations and strategic input to senior management and cross‑functional teams to support drug development decisions; br / br / /liliDevelops statistical analysis plans for studies, performs complicated statistical analyses, and oversees the generation of tables, listings and figures for clinical study reports, regulatory submission, and publications ensuring high‑quality, and consistent statistical deliverables; br / br / /liliProvides oversight of external vendors and CRO partners to ensure high‑quality, timely, and compliant statistical deliverables and services; br / br / /liliReviews regulatory documents for accuracy and appropriateness of statistical methodologies and interpretations and serves as statistical liaison with regulatory authorities; br / br / /liliReviews and approves statistical content of clinical trial publications, abstracts, and manuscripts ensuring rigorous interpretation and communication of analysis results; br / br / /liliBuilds and maintains productive internal and external partnerships to support effective cross‑functional collaboration ; br / br / /liliCommunicates effectively with team members, senior management, external experts, vendors and regulatory authorities. /liliEnsures that statistical activities are conducted in compliance with applicable regulatory, GxP, and company requirements and promotes ethical business practices. /liliContributes to the advancement of statistical methodologies by evaluating and implementing innovative approaches to support drug research and development; br / br / monitors emergingdata science and artificial intelligence technologies and leverages them to improve efficiency, analytical quality, and data‑driven decision‑making across development programs . /li /ulRequirements:ulliPhD in Biostatistics/Statistics or related areas with a minimum of 7 years of relevant pharmaceutical or biotechnology experience or a Master’s degree with a minimum of 10 years of relevant experience; br / br / /liliStrong knowledge of statistical methodology for the design, analysis, and interpretation of clinical studies; br / br / /liliKnowledgeof linear and generalized linear models, including repeated measures analyses, mixed effects models, categorical data analysis, and time‑to‑event data required ; br / br / /liliExperience withadaptive clinical trial des