Manager, Nonclinical Statistics

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Are you looking for a patient-focused, innovative company that will inspire you and empower you to shine? Join us as Manager of Nonclinical Statistics in our Cambridge, MA office.

As a Manager of Statistics, you will provide statistical leadership across Nonclinical functions. We seek a driven, inquisitive statistician, excited to use experimental design, advanced statistical tools, and decision theory to ultimately improve patient access to modern medicines. The remit of the successful candidate will span across both Chemicals, Manufacturing, and Controls (CMC) and focused areas of drug discovery with specific support to preclinical and clinical biomarker assay development and validation.

• Provide statistical support and leadership for Takeda CMC campaigns for design and analysis in analytical development and formulation development for synthetic molecules, biologics, cell therapies, and other drug modalities.
• Provide statistical support and leadership for Takeda preclinical and clinical biomarker assay development and validation.
• Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement CMC strategies to enable data driven decision making.
• Apply frequentist, Bayesian, ML/AI fit‑for‑purpose statistical analyses across various projects and data types across the preclinical R&D arena.

• Contribute to and/or serve as lead representing data science function on project teams in support of nonclinical studies throughout analytical development, formulations development, and other CMC functions.
• Develop and validate preclinical and clinical biomarker assays for all therapeutic areas.
• Perform end‑to‑end data analyses, from hypotheses formulation, experimental design, writing analysis plans, data cleaning, executing analysis, and preparing reports and documentation.
• Strengthen Takeda’s advanced analytics toolkit by identifying and applying emerging techniques, as well as by developing novel analysis tools as needed.
• Collaborate effectively within a matrix environment, working with scientists across various areas to understand the problems in terms of its chemistry, biology, and/or physical natures and to tailor data analyses to program‑specific needs.
• Work closely with Takeda statisticians to ensure statistical issues in data analysis are addressed.
• Communicate internal and external resource and quality issues that may impact deliverables or timelines of the program. Escalate issues to management as appropriate in a timely manner.
• Respond to regulatory questions that are statistical in nature.
• Increase the external recognition of Takeda’s data science work by participating in conferences, publishing work and developing external collaborations.

• Education in a relevant field, for example a) PhD in a field such as Statistics, Physics, Electrical Engineering, Biomedical Engineering, Computer Science, Applied Mathematics with some relevant experience (including internships and research assistance ships), or b) Master’s degree with a minimum of 3 years of relevant experience.
• Hands on experience with and strong interest in some of the relevant fields of CMC and/or assay development and validation.
• Expert‑level knowledge of data science programming languages (R, Python, or similar) and experience with recommended practices for software development.
• Ability to work independently on complicated datasets, including all aspects of data analysis (data cleaning, algorithm development, statistical analysis, and documentation).
• Excellent oral and written communications skills.
• Willingness and ability to self‑educate in new areas.
• Knowledge of FDA, EMA, and ICH regulations and industry standards applicable to the CMC is a plus.

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