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CAREER OPENINGS


Sr. Director, Biostatistics

ID: 1594
Department: Biometrics
Location: Cambridge Headquarters
# of Openings: 1

Description

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.

 

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 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.

 

Responsibilities:

  • Contribute statistical expertise to the clinical development strategy and development plan on emerging drug products;

  • Design, analyze, and prepare reports of individual clinical trials and regulatory submissions (e.g., Summary of Clinical Efficacy);

  • Author, review, and approve clinical protocols, clinical study reports including authorship of key sections (sample size, methods, missing data, etc.) and conclusions, and primary and secondary manuscripts of clinical trial results;

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

  • Act as statistical liaison to FDA/regulatory agencies, CROs, external partners, and third- party data vendors;

  • Provide management of individual clinical trials and development programs;

  • Research advanced and innovative statistical methods to integrate into the clinical development programs; author and update departmental SOPs or work tools following best statistical practices and FDA expectations per ICH guidance.

  • Occasional travel.

 

Requirements:

  • Advanced degree in biostatistics, statistics, or related field (e.g., pharmacometrics);

  • Minimum 14 years of experience designing and analyzing clinical trials;

  • Experience in a regulatory environment within biopharmaceutical product development;

  • Ability to provide statistical leadership for multiple projects; managing internal resources as well as outsourced trials and programs; 

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

  • Strong communication and presentation skills, both verbal and written, with the ability to inform and influence;

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

  • Good organizational and problem-solving skills;

  • Willing to mentor. 


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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