Senior Biostatistics Manager

3 weeks ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
The Role:

This is an exciting opportunity to be a critical part of the clinical development group of a high-growth organization.

The Senior Manager of Biostatistics will be involved in the design, execution, analysis, and reporting of clinical studies with a focus on Moderna's infectious disease vaccine programs.

This position will be located in Cambridge, MA.

Key Responsibilities:
  • Serve as the biostatistician in clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time.
  • Responsible to bring innovative statistical thinking and operational excellence to help drive applications of state-of-the-art statistical methods that increase the probability of successes for clinical development programs.
  • Develop statistical sections of protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses.
  • Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence.
  • Contribute to SOPs and/or Work Instructions related to biostatistics practices.
  • Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals.
Requirements:
  • MS or PhD (or equivalent degree) with 5+ years (PhD) or 7+ years (MS) of relevant work experience in Biotech, Pharma, Regulatory authorities, or Clinical Research Organizations.
  • Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems.
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • Experience working on prophylactic vaccine clinical studies and regulatory interactions are 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 effectively in a dynamic, cross-functional matrix environment.
What We Offer:
  • 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, discretionary year-end shutdown, and paid sabbatical after 5 years.
  • 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.
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.

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.

We are committed to offering reasonable accommodations to qualified job applicants with disabilities.

We are an E-Verify Employer in the United States and an affirmative action employer.

We are 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.

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