Sr. Statistician, CMC Quantitative Sciences

The Role

In this role, you will provide strategic statistical guidance and leadership to project teams. Working collaboratively with cross-functional teams, you will partner with colleagues in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research. Your understanding of these domains will be essential in identifying the most effective statistical approaches to address complex research questions and drive the scientific decision-making process.  Your role will focus on the application of statistical methods and will also involve fostering a culture of statistical excellence within the organization. By teaching statistical principles and championing data-driven strategies, you will contribute to the development of a robust statistical framework that enhances our research and production capabilities.

The ideal candidate will be self-motivated with outstanding communication skills, embodying the Moderna core values of being Bold, Collaborative, Curious, and Relentless. Your strategic input will be critical in maintaining our position at the forefront of therapeutic innovation, as we expand our pipeline and build technical platforms to meet the rapid pace of biotechnological advancement.

Here’s What You’ll Do

• Serve as strategic partner to product teams, providing project-specific support on justification of specifications, shelf-life analysis, comparability assessments, and investigational analysis

• Provide consultation to internal stakeholders, appropriately addressing research questions by designing proper experiments & matching correct statistical tools to requests

• Collaborate with scientists, engineers, and other statisticians to facilitate data-driven decision making, fostering a common understanding of statistical principles and interpretation of analysis conclusions

• Clearly articulate complex analysis methodology & findings to a diverse audience, including non-statistician partners, stakeholders, and management

• Embed statistical thinking throughout the organization by educating scientists on statistical tools and their application

• Contribute to regulatory filings by authoring & reviewing statistical content in module 3 of IND, IMPD, BLA, and MAA dossiers

• Act as subject matter expert for statistical aspects of the analytical method lifecycle, including method development, qualification, validation, and investigations

• Partner with process development teams to enhance our platform by applying Quality by Design principles to process characterization and process change activities

• Adhere to best statistical practices to drive consistency across CMC statistics and Moderna’s platform.

• Act as key advisor to scientist partners

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Minimum Qualifications)

• PhD in Statistics or related discipline with 3 - 5 years of relevant experience; MS degree in Statistics or related discipline with 6 - 8 years of relevant experience; or BS degree in Statistics or related discipline with 8 - 10 years of relevant experience

• Deep understanding of statistical methods such as Design of Experiments (DOE), regression modeling, variance component analysis, multivariate analysis, process capability, and control charts

• Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background

• Advanced skills using one or more statistical packages or languages (e.g., JMP, SAS, or R)

• Ability to instruct non-statisticians in basic & intermediate statistical methods

• Outstanding communication skills, both verbal and written

• Proficiency with Microsoft Office suite (i.e. Word, Excel, PowerPoint)

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Familiarity with GMP quality concepts used in pharmaceutical production and development

• Regulatory writing experience, including eCTD submissions and response to health authority questions

• Thorough comprehension of regulatory guidance, including ICH, WHO, USP guidelines

• Experience with phase appropriate GMP principles

• Understanding of risk analysis 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 skill