Statistics Manager

2 weeks ago

Cambridge, Massachusetts, United States Takeda Pharmaceuticals Full time
Job Title: Manager of Statistics

We are seeking a highly skilled Manager of Statistics to join our team at Takeda Pharmaceuticals. As a Manager of Statistics, you will be responsible for providing statistical leadership in the design, analysis, and interpretation of chemicals, manufacturing, and controls (CMC) study data throughout Pharmaceutical Sciences.

Key Responsibilities:
  • 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.
  • 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.
Requirements:
  • 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.
What Takeda Can Offer You:
  • 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
  • Empowering Our People to Shine

We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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