Biostatistics Manager

6 days ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
About the Role

We are seeking a highly skilled Biostatistics Manager to join our Clinical Development team at Moderna Therapeutics. As a key member of our team, you will be responsible for leading the design, execution, analysis, and reporting of clinical studies, with a focus on our infectious disease vaccine programs.

Key Responsibilities
  • Develop and implement statistical plans for clinical studies, ensuring high-quality and timely deliverables.
  • Collaborate with cross-functional teams to drive the application of innovative statistical methods and operational excellence.
  • Plan, manage, and track biostatistics activities, timelines, and resources to ensure operational excellence.
  • Contribute to the development of Standard Operating Procedures (SOPs) and Work Instructions related to biostatistics practices.
  • Manage internal and external relationships with vendors, CROs, and clinical development partners to ensure project timelines and goals are met.
Requirements
  • Master's or Ph.D. degree in Biostatistics, Statistics, or a related field.
  • 5+ years of relevant work experience in Biotech, Pharma, Regulatory authorities, or Clinical Research Organizations.
  • Excellent statistical knowledge and ability to apply it to solve scientific and clinical problems.
  • Working knowledge of relevant FDA, EU, and ICH guidelines and regulations.
  • Experience working on prophylactic vaccine clinical studies and regulatory interactions is preferred.
  • Experience working with CROs, vendors, and relationship management.
  • Outstanding communication skills (verbal and written).
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
About Moderna Therapeutics

Moderna Therapeutics is a leading biotechnology company that is pioneering the use of messenger RNA (mRNA) technology to develop novel therapeutics. We are committed to advancing the field of mRNA technology and improving the lives of patients worldwide.

We offer 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

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