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Job Description

Are you a dedicated professional passionate about patient care and career growth? At Takeda, we empower you to shape your future. Join us as a Manager of Statistics at our Cambridge, MA office, where every individual’s contribution is valued.

In this vital role, you’ll play a key part in our bold and inspiring mission. As Manager of Statistics, you will provide statistical leadership in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls (CMC) study data throughout Pharmaceutical Sciences. We seek an innovative and inquisitive statistician, excited to use advanced statistical tools to enhance CMC projects and improve patient access to modern medicines. 

For more information on CMC, click here , here , and here .

OBJECTIVE: 

• Provide statistical support for Takeda CMC campaigns for design and analysis in analytical development and formulation development for synthetic molecules, biologics, cell therapies, and other drug modalities.
• 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.

ACCOUNTABILITIES: 

• Contribute to representing data science function on project teams in support of nonclinical studies throughout analytical development, formulations development, and other CMC functions.
• 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, EXPERIENCE AND SKILLS:

• 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 assistanceships), or b) Master’s degree with a minimum of 3 years of relevant experience
• 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.

This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Empowering Our People to Shine

Learn more at takedajobs.com .

No Phone Calls or Recruiters Please.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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