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.
Heres What Youll 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 Modernas platform.
Act as key advisor to scientist partners
Additional duties as may be assigned from time to time
Heres What Youll 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)
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:
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 modernatx.com/careers 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
leavesandaccommodations@modernatx.com
. (EEO/AAP Employer)-
Skills:
Analysis Skills, Analytical Development, Best Practices, Channel Strategies, Communication Skills, Comparative Analysis, Cross-Functional, Data Analysis, Detail Oriented, Diversity, Drug Development, Experiment Design, Family Planning, Financial Planning, Fitness, GMP (Good Manufacturing Practices), Health Plan, Leadership, Manufacturing, Marketing Authorization Application (MAA), Medical Products, Medicine, Mentoring, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Multivariate Analysis, Nutrition, Presentation/Verbal Skills, Pricing, Process Capability, Process Development, Project/Program Management, R Programming Language, Regulations, Regulatory Submissions, Risk, Risk Analysis, Statistical Analysis System (SAS), Statistics, Team Player, Training/Teaching, United States Department of Energy (DOE), Variance Analysis, Writing Skills
About the Company:
Moderna, Inc.
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