Senior Manager of Statistics- CMC
Company: Takeda
Location: Cambridge
Posted on: December 31, 2025
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Job Description:
By clicking the “Apply” button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda’s Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description Are you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a Senior Manager of
Statistics- CMC in our Cambridge, MA office. As a Senior 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. This role will also support
clinical/biomarker assay development and validation. For more
information on CMC, click here , here , and here . At Takeda, we
are transforming the pharmaceutical industry through our
R&D-driven market leadership and being a values-led company. To
do this, we empower our people to realize their potential through
life-changing work. Certified as a Global Top Employer, we offer
stimulating careers, encourage innovation, and strive for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world. Here, you will be a vital
contributor to our inspiring, bold mission. POSITION OBJECTIVES:
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 clinical and 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. POSITION ACCOUNTABILITIES: 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 validation clinical and 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, BEHAVIORAL COMPETENCIES AND SKILLS:
Education in a relevant field, for example a) PhD in a field such
as (Bio)statistics, Physics, Electrical Engineering, Biomedical
Engineering, Computer Science, Applied Mathematics with at least an
additional 3 years of experience in a statistical or quantitative
field, or b) Master’s degree with a minimum of 6 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. This position is currently classified as “ hybrid ” in
accordance with Takeda’s Hybrid and Remote Work policy. Empowering
Our People to Shine Discover more at takedajobs.com No Phone Calls
or Recruiters Please. 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. For Location: USA - MA - Cambridge U.S. Base Salary
Range: $137,000.00 - $215,270.00 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-termincentives. 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. 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. Locations USA - MA - Cambridge
Worker Type Employee Worker Sub-Type Regular Time Type Full time
Job Exempt Yes It is unlawful in Massachusetts to require or
administer a lie detector test as a condition of employment or
continued employment. An employer who violates this law shall be
subject to criminal penalties and civil liability.
Keywords: Takeda, Nantucket , Senior Manager of Statistics- CMC, Science, Research & Development , Cambridge, Massachusetts
