Takeda · 6 days ago
Senior Manager, Nonclinical Statistics
Cambridge, MA
Full-time
Hybrid
Senior Level
$137K/yr - $215K/yr
6+ years expTakeda is a patient-focused, innovative pharmaceutical company seeking a Senior Manager of Nonclinical Statistics in their Cambridge, MA office. The role involves providing statistical leadership and support for nonclinical functions, including analytical and formulation development, as well as preclinical and clinical biomarker assay development.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
Knowledge of FDA, EMA, and ICH regulations and industry standards applicable to the CMC is a plus
Benefits
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
Company data provided by crunchbase