Senior Scientist, CMC Quantitative Analytics

Moderna; Norwood (MA); On-site; USD 131,000 - 209,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning benefits

Paid time off

Savings & investments

Location-specific perks

Job summary

Moderna seeks a Senior Scientist to join the CMC Quantitative Sciences team in Norwood, MA. This 100% onsite role leads statistical support for analytical methods and product lifecycles, mentors teams, and shapes regulatory submissions with advanced analytics.

You will collaborate with Operations, Quality, Manufacturing Science, Analytical Development, and Technical Development to advance monitoring tools and data products, driving statistical excellence across the platform.

Qualifications

• PhD in Statistics (2+ yrs), MS (8 - 10 yrs), or BS (10 - 15 yrs) in Statistics, Biostatistics, Data Science, Applied Mathematics, Chemical Engineering, Biochemical Engineering, or a related STEM discipline.
• Strong foundation in applied statistical methods such as DOE, regression, capability analysis, control charts, and multivariate analysis
• Experience with analytical method lifecycle and/or product development lifecycle activities in a regulated environment
• Demonstrable experience with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data
• Effective communicator who can translate statistical thinking into actionable strategies for non-statistical audiences
• Understanding of regulatory guidance (e.g., ICH, FDA, EMA, WHO)

Responsibilities

• Lead statistical support for analytical method and product lifecycle activities, including pre-pivotal, clinical, and commercial programs
• Serve as a subject matter expert on statistical aspects of research and CMC activities, guiding experimental design, data analysis, and decision-making
• Contribute to regulatory filings by authoring and reviewing statistical content for items such as comparability, analytical methods, stability, in regulatory submissions
• Drive analytical monitoring innovation by developing automated data monitoring systems and integrating industry best practices in product and analytical lifecycle activities
• Partner cross-functionally with scientists, engineers, and quality teams to ensure experiments are well-designed and statistical methods are appropriately applied
• Educate partners by building statistical literacy and promoting the use of sound statistical reasoning in decision-making
• Communicate clearly to both technical and non-technical audiences, translating complex analyses into actionable insights
• Champion statistical best practices to promote consistency, rigor, and scalability across CMC QS and the Moderna platform
• Stay current and contribute to the field through literature review, training, and conference engagement

Skills

Statistical methods

DOE

Regression

Capability analysis

Control charts

Multivariate analysis

R

Python

SQL

JMP

Statistica

Minitab

Effective communicator

Regulatory knowledge

Education

PhD in Statistics (2+ yrs)

MS in Statistics/Data Science (8-10 yrs)

BS in Statistics/Data Science (10-15 yrs)

Tools

JMP

Statistica

Minitab

Job description

Moderna seeks a Senior Scientist to join the CMC Quantitative Sciences team in Norwood, MA. This 100% onsite role leads statistical support for analytical methods and product lifecycles, mentors teams, and shapes regulatory submissions with advanced analytics.

You will collaborate with Operations, Quality, Manufacturing Science, Analytical Development, and Technical Development to advance monitoring tools and data products, driving statistical excellence across the platform.