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Career Openings

Sr. Director, Biostatistics

ID: 1449
Department: Clinical Affairs Administration
Location: Cambridge Headquarters
# of Openings: 1


Functional area: Biostatistics


Position description:

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.



  • Evaluate information from the statistical literature, government agencies, and outside experts relevant to ongoing projects;

  • Act as statistical liaison to FDA/regulatory agencies;

  • Develop, document, and maintain processes according to GXP principles and best practices;

  • Promote and integrate statistical methods into the drug development process;

  • Act as the technical reviewer of work product generated by Biostatistics staff;

  • Serve as statistical liaison with CROs and third party data vendors;

  • Review and approve clinical protocols and clinical study reports including authorship of key sections (sample size, methods, missing data, etc.) and conclusions;

  • Ensure that protocols and statistical analysis plans are followed throughout the course of analysis and reporting - documenting assumptions, decisions, changes, and conclusions;

  • Set and manage project timelines within Biostatistics;

  • Provide comprehensive status updates to department and project team members;

  • Implement analysis standards grounded in the statistical literature; build worktools to facilitate the implementation of analysis and reporting standards;

  • Follow and enhance quality system applicable to best statistical practices and FDA expectations per ICH guidance (e.g., author and update select SOPs or worktools, as needed, and requested by Data Science management).




  • Advanced degree in biostatistics, statistics, or related field (e.g., pharmacometrics) as well as experience in a regulatory environment within biopharmaceutical product development;

  • Minimum 16 years of relevant pharmaceutical/biotechnology experience;

  • Knowledge of linear models, including repeated measures analyses and mixed effects models, categorical data analysis, and time to event data required; experience with exact methods desirable;

  • Experience in supporting Phase 1 studies as well as early-phase studies to support development program decisions (“go/no go”) and dose selection;

  • Experience in late-phase pivotal trials as well as post-approval trials and registries;

  • Ability to contribute at a strategic level to program plans and product development in collaboration commercial stakeholders (e.g., New Products Planning);

  • Experience in providing statistical input into protocol study design, writing analysis plans, and the regulatory and scientific reporting of clinical research;

  • Proficiency in SAS programming – StatExact, NQuery, and R experience desirable;

  • Demonstrated proficiency initiating and managing clinical trials as well as outsourcing trials and programs;

  • Knowledge of, and experience with CDISC standards, medical terminology, FDA regulatory process (e.g., “milestone” meetings), and applicable ICH guidelines;

  • Good organizational and problem-solving skills;

  • Detail-oriented with strong quantitative, written, and communication skills;

  • A person who can understand and clearly communicate complex information, exercise excellent judgment, and engender respect within the organization;

  • Excels in a collaborative team-oriented environment;

  • Must be able to manage multiple initiatives and shifting priorities within a small company environment;

  • Occasional travel.

Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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