Principal Statistician, CMC Quantitative Sciences

Moderna, Inc.; Norwood (MA); On-site; USD 90,000 - 160,000; Full time

Job summary

An innovative company is seeking a Principal Scientist to lead statistical strategies in analytical method lifecycle activities. This role involves mentoring, applying advanced statistical methods, and contributing to regulatory submissions. The ideal candidate thrives in a fast-paced environment, enjoys problem-solving, and is passionate about statistical excellence. Join a team that values collaboration and innovation, making a significant impact in the field of medicine. If you are driven and eager to contribute to groundbreaking work, this opportunity is for you.

Benefits

Best-in-class healthcare coverage

Holistic well-being support

Lifestyle Spending Accounts

Family planning benefits

Generous paid time off

Savings and investment opportunities

Location-specific perks

Qualifications

• PhD or MS in Statistics with extensive experience in applied statistical methods.
• Experience in analytical method validation in a regulated environment.

Responsibilities

• Lead statistical support for analytical method lifecycle activities.
• Guide statistical aspects of method development and regulatory filings.

Skills

Applied Statistical Methods

Statistical Analysis

Communication Skills

Problem-Solving

Leadership

Mentoring

Education

PhD in Statistics

MS in Statistics

BS in Statistics

Tools

JMP

R

SAS

Job description

The Role:

Moderna is seeking a strategic, hands-on Principal Scientist to join the CMC Quantitative Sciences (QS) team in Norwood, MA. As a key member of the team, you will lead statistical strategy and execution for analytical method lifecycle activities and applied modeling for analytical instrumentation across clinical, late-stage, and commercial programs.

You will serve as the primary statistical thought partner to Analytical Development and Quality, guiding phase-appropriate strategies for method development, validation, transfer, and monitoring. In addition to traditional statistical techniques, you will apply quantitative and machine learning methods to analytical technologies and contribute to the implementation of next-generation QC tools, including automation and high-throughput analytics. You will also support regulatory submissions and help shape Moderna's statistical approach to data monitoring and method comparability.

Beyond your technical contributions, you will mentor others and help build a culture of statistical excellence across CMC. This is an ideal role for someone who thrives in applied problem-solving, enjoys coaching, and wants to make a tangible impact in a high-paced, science-first environment.

The ideal candidate is self-driven, an excellent communicator, and aligned with Moderna's core values of being Bold, Collaborative, Curious, and Relentless. Your leadership will help ensure our statistical approaches remain innovative, scalable, and essential to the success of our growing therapeutic platform.

Here's What You'll Do:

• Lead statistical support for analytical method lifecycle activities, including method development, validation, transfer, and investigations across clinical, late-stage, and commercial programs
• Serve as a subject matter expert on statistical aspects of the analytical method lifecycle, guiding experimental design, data analysis, and decision-making
• Contribute to regulatory filings by authoring and reviewing statistical content for reference standards, method validation, and method transfer in regulatory submissions
• Drive analytical monitoring innovation by developing automated QC data monitoring systems and integrating industry best practices in analytical method lifecycle activities
• Support next-generation analytics by enabling automated QC, high-throughput Raman, and advanced integration of complex chromatographic methods
• Guide post-approval changes, including reference standard updates and analytical method optimizations
• Partner cross-functionally with scientists, engineers, and quality teams to ensure experiments are well-designed and statistical methods are appropriately applied
• Educate and influence partners by building statistical literacy and promoting the use of sound statistical reasoning in analytical 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 (5+ yrs), MS (8 - 10 yrs), or BS (10 - 15 yrs) in Statistics or a related field
• Strong foundation in applied statistical methods such as DOE, regression, capability analysis, control charts, and multivariate analysis
• Experience with analytical method validation and lifecycle activities in a regulated environment
• Proficiency in JMP, R, or SAS
• Effective communicator who can translate statistical thinking into actionable strategies for non-statistical audiences
• Understanding of regulatory guidance (ICH Q2/Q14, USP, Ph.Eur., 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
• Proven mentoring or people management experience

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

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are 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 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements.

We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 [e-mail]. (EEO Employer)
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