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Moderna

Develops mRNA-based medicines for health

Senior Scientist - CMC Quantitative Sciences

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeNorwood, MA, USA

About the Job

Requirements

  • A PhD in Statistics with at least 2 years of experience, an MS in Statistics, Biostatistics, Data Science, Applied Mathematics, Chemical Engineering, Biochemical Engineering, or a related STEM discipline with 8–10 years of experience, or a BS in those fields with 10–15 years of experience.
  • A strong foundation in applied statistical methods, including design of experiments, regression, capability analysis, control charts, and multivariate analysis.
  • Experience with analytical method lifecycle and/or product development lifecycle activities in a regulated environment.
  • Demonstrable experience with computer languages such as R, Python, or SQL and statistical software packages such as JMP, Statistica, or Minitab to manipulate and analyze data.
  • Ability to translate statistical thinking into actionable strategies for non-statistical audiences.
  • Understanding of regulatory guidance such as ICH, FDA, EMA, and WHO.
  • Ability to balance practical importance, business impact, and scientific rigor in decision-making.
  • Ability to collaborate in a cross-functional matrix organizational structure.
  • Ability to manage multiple projects in a dynamic environment.
  • Attention to detail and interest in science and data analysis.
  • Self-motivation and strong communication skills.
  • Ability to learn, adapt, and pivot in response to new data.

Responsibilities

  • Lead statistical support for analytical method and/or product lifecycle activities, including pre-pivotal, clinical, and commercial programs.
  • Serve as a subject matter expert on statistical aspects of research and CMC activities, guiding experimental design, data analysis, and decision-making.
  • Author and review statistical content for regulatory filings, including comparability, analytical methods, and stability submissions.
  • Develop automated data monitoring systems and integrate industry best practices in product and analytical lifecycle activities.
  • Partner with scientists, engineers, and quality teams to ensure experiments are well-designed and statistical methods are appropriately applied.
  • Educate partners, build statistical literacy, and promote sound statistical reasoning in decision-making.
  • Communicate complex analyses as actionable insights to technical and non-technical audiences.
  • Promote statistical best practices to support consistency, rigor, and scalability across CMC Quantitative Sciences and the broader Moderna platform.
  • Stay current and contribute to the field through literature review, training, and conference engagement.
  • Mentor others and help build a culture of statistical excellence across CMC.

Desired Qualifications

  • Familiarity with eCTD submissions and responding to health authority 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.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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