Senior Manager of Statistics- CMC

Role Summary

Senior Manager of Statistics- CMC in Cambridge, MA. Provide statistical leadership in design, analysis, and interpretation of CMC study data; support clinical/biomarker assay development and validation.

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 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.

Qualifications

• Education in a relevant field, for example a) PhD in (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 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.

Skills

• Data science programming (R, Python, or similar)
• Statistical analysis design and execution
• Scientific communication and documentation
• Regulatory knowledge related to CMC (FDA/EMA/ICH) a plus

Education

• PhD in a relevant field or Master’s degree with substantial relevant experience as described above

Additional Requirements

• Hybrid work arrangement as per policy