- 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 Modernas 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
- Additional duties as may be assigned from time to time Heres What Youll Need (Minimum Qualifications)
- PhD in Statistics or related discipline with 5 - 8 years of relevant experience; MS degree in Statistics or related discipline with years of relevant experience; or BS degree in Statistics or related discipline with years of relevant experience
- Mastery 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
- Exceptional communication skills, both verbal and written
- Proficiency with Microsoft Office suite (i.e. Word, Excel, PowerPoint) Heres What Youll 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 skills
- Keen to learn & adapt, with the ability to pivot in the face of new data
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter - Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)#LI-DS1
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Principal Statistician, CMC Quantitative Science - Norwood, United States - Moderna, Inc.
Description
The Role
Moderna is seeking an accomplished Principal Statistician to join our Chemistry, Manufacturing, and Controls (CMC) Quantitative Sciences team onsite in Norwood, MA. As a pivotal member of the CMC Statistics team, 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 deep 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 not only focus on the application of statistical methods but will also involve mentoring and 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 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.
Heres What Youll Do
