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Principal / Senior Principal Statistician

Boston, Massachusetts


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Principal / Senior Principal Statistician

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Job ID R0020966 Date posted 06/26/2020 Location Boston, Massachusetts

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Job Description

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Principal / Sr. Principal Statistician in our Statistical & Quantitative Sciences-Gastrointestinal (SQS-GI) organization, in Takeda’s Cambridge, MA office location.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. As a statistician working in the GI Therapeutic Area (TA), you will be empowered to provide statistical leadership in the design, analysis, and interpretation of clinical studies for compounds that make up Takeda’s GI portfolio.  The role involves promoting and implementing innovative clinical trial design, statistical modeling and quantitative decision-making for all stages of GI drug development (phase 1 through phase 4). The SQS organization at Takeda is part of the Takeda’s Data Science Institute (DSI).  Consequently, the role also offers opportunities to explore and work on applications of data science-focused approaches (e.g., machine learning) to drug-development, in addition to traditional statistical methods.


  • Provide statistical leadership in the design, analysis, and interpretation of clinical trials at a study and program or compound-level , promoting innovative design, quantitative decision-making, statistical modeling, data sciences and advanced statistical analysis methods.
  • Provide strategic statistical input for feasibility assessments, clinical development plans, regulatory submissions/interactions and medical-evidence generation.
  • Independently represent the Statistics function in interactions with regulatory authorities and other internal/external stake-holders.
  • Monitor and implement statistical advances in clinical trial design/analysis and drug-development (phase 1 to phase 4) strategy, including data-science-focused applications and the use of external data sources (such as real-world data).


  • Partner with Clinicians to promote innovative clinical trial designs and efficient analysis methods
  • Provide strategic statistical input for feasibility assessments (including timelines), development and submission plans, and product defense
  • Provide statistical leadership in the development and review of study protocols, statistical analysis plans, clinical study reports, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
  • Collaborate with Data Management, Programming, Clinical Operations, Clinical and Safety functions to ensure timely and high-quality reporting deliverables for trials and submissions.
  • Provide statistical oversight of trial reporting deliverables that have been outsourced to external vendors
  • Contribute to the Statistics function, through the development of innovative statistical analysis and data-sciences methodology, functional standards and best practices to introduce process efficiencies.
  • Leverage scientific expertise for strategic statistical leadership by providing recommendations (based on quantitative decision-making) to senior management.
  • Lead or contribute to publication strategy for generating medical evidence for approved products


  • PhD in Statistics or Biostatistics with a minimum of 2 to 8 years of relevant experience or MS in statistics or biostatistics with a minimum of 6 to 12 years of relevant experience.
  • Excellent oral and written communications skills
  • Ability to communicate technical concepts to a non-technical audience
  • Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures.
  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
  • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
  • Expertise in statistical programming, modeling and simulations 


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs


Boston, MA

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Full time

Job ID R0020966

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