Sr. Scientist, CMC Quantitative Sciences
Moderna
Summary
Moderna is seeking a strategic, hands-on Senior Scientist to join the CMC Quantitative Sciences (QS) team in Norwood, MA. As a key member of the team, you will serve as a statistical thought partner to Operations, Quality, Manufacturing Science and Technology, Analytical Development, and Technical Development organizations.
Job description
Here's What You'll Do
- Lead statistical support for analytical method and/or 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 broader Moderna platform
- Stay current and contribute to the field through literature review, training, and conference engagement
Here's What You'll Bring to the Table
Minimum 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).
Preferred Qualifications: Familiarity with eCTD submissions and response to HA questions. Experience with analytical QC automation, high-throughput methods, or large-scale monitoring systems. Knowledge of phase-appropriate GMP principles and risk-based decision making.
Competencies
- Skilled at balancing practical importance, business impact, and scientific rigor associated with decisions
- Strong collaborative skills in a cross-functional matrix organizational structure
- Capable of managing multiple projects in a dynamic environment
- Detail-oriented with a passion for science and data analysis
- Self-motivated with outstanding communication skills
- Keen to learn & adapt, with the ability to pivot in the face of new data
Requirements
- 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)
- Familiarity with eCTD submissions and response to HA questions
- Experience with analytical QC automation, high-throughput methods, or large-scale monitoring systems
- Knowledge of phase-appropriate GMP principles and risk-based decision making
- Skilled at balancing practical importance, business impact, and scientific rigor associated with decisions
- Strong collaborative skills in a cross-functional matrix organizational structure
- Capable of managing multiple projects in a dynamic environment
- Detail-oriented with a passion for science and data analysis
- Self-motivated with outstanding communication skills
- Keen to learn & adapt, with the ability to pivot in the face of new data
Benefits
- Competitive healthcare
- Voluntary benefit programs
- Fitness support
- Mindfulness support
- Mental health support
- Fertility support
- Adoption support
- Surrogacy support
- Generous paid time off
- Volunteer days
- Sabbatical
- Global recharge days
- Year-end shutdown
- Savings and investments
- Location-specific perks
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.