Description:
The ideal candidate will be self-motivated with exceptional communication skills, embodying the Moderna core values of being Bold, Collaborative, Curious, and Relentless. Your strategic input and mentorship 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 senior 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
- Strongly partner with process development teams to enhance our platform by applying Quality by Design principles to process characterization and process change activities
- Set, maintain, and model best statistical practices to drive consistency across CMC statistics and Moderna’s platform.
- Mentor junior team members & act as key advisor to scientist partners
- Continue to advance & share your knowledge of relevant CMC topics through literature, training, & conference attendance
- Potential to act as Team Lead 2 within Moderna’s Team Leads model: team leader is responsible for tactical management of daily activities of small team of CMC statisticians
- Additional duties as may be assigned from time to time
Here’s What You’ll Need (Basic Qualifications)
- PhD in Statistics or related discipline with 5 - 8 years of relevant experience; MS degree in Statistics or related discipline with 8 - 10 years of relevant experience; or BS degree in Statistics or related discipline with 10 - 15 years of relevant experience