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Senior Quantitative Sciences Leader

2 months ago

Norwood, Massachusetts, United States Moderna Full time
About the Role

We are seeking a highly skilled and experienced Senior Quantitative Sciences Leader to join our team at Moderna. As a pivotal member of our 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.

Key Responsibilities

  • Serve as a 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 a 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 a 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.

Requirements

  • 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.

Preferred Qualifications

  • 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).
  • 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.