Associate Director, Biostatistics

 

Ironwood 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 R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland

 

Purpose/Summary: 

The 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.

Additional responsibilities include maintaining expertise in applicable regulatory guidance and industry best practices and promoting compliance through SOP development and training; leading the evaluation and implementation of innovative statistical methodologies to support drug development; and overseeing external vendors and CRO to ensure high quality, timely and compliant deliverables.  

Essential Functions:  

• Serves 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; 

• Provides statistical inputs to clinical development plans, regulatory strategies, and life cycle planning; 

• Provides statistical consultations and strategic input to senior management and cross-functional teams to support drug development decisions; 

• Develops 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; 

• Provides oversight of external vendors and CRO partners to ensure high-quality, timely, and compliant statistical deliverables and services; 

• Reviews regulatory documents for accuracy and appropriateness of statistical methodologies and interpretations and serves as statistical liaison with regulatory authorities; 

• Reviews and approves statistical content of clinical trial publications, abstracts, and manuscripts ensuring rigorous interpretation and communication of analysis results; 

• Builds and maintains productive internal and external partnerships to support effective cross-functional collaboration; 

• Communicates effectively with team members, senior management, external experts, vendors and regulatory authorities. 

• Ensures that statistical activities are conducted in compliance with applicable regulatory, GxP, and company requirements and promotes ethical business practices.  

• Contributes to the advancement of statistical methodologies by evaluating and implementing innovative approaches to support drug research and development; monitors emerging data science and artificial intelligence technologies and leverages them to improve efficiency, analytical quality, and data-driven decision-making across development programs. 

 

Requirements: 

• PhD 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; 

• Strong knowledge of statistical methodologies for the design, analysis, and interpretation of clinical studies; 

• Knowledge of linear and generalized linear models, including repeated measures analyses, mixed effects models, categorical data analysis, and time-to-event data required;  

• Experience with adaptive clinical trial designs, estimands, missing data methodologies, simulations and Bayesian methods is desirable; 

• Knowledge of FDA and ICH guidelines, CDISC standards and implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines;  

• Experience interacting with FDA and/or other regulatory agencies desirable; 

• Experience supporting regulatory submission is desirable; 

• Strong knowledge of statistical analysis software, including SAS and R; familiarity with version control and collaborative development tools (e.g., Git/GitLab) and AI-assisted analytical workflows is desirable. 

• Excellent analytical, problem-solving and computer skills; 

• Excellent verbal and written communication skills, with the ability to communicate complex statistical concepts to technical and non-technical audiences; 

• Strong interpersonal skills and demonstrated ability to collaborate effectively in cross-functional teams; 

• Ability to work independently, manage multiple priorities, and perform effectively in a fast-paced environment;  

• Fluent in spoken and written English.