Senior Manager of Biostatistics
4 weeks ago
About the Role:
This is an exciting opportunity to be a critical part of the clinical development group of a high growth organization. As a Senior Manager of Biostatistics, you will be involved in the design, execution, analysis, and reporting of clinical studies with a focus on Moderna's infectious disease vaccine programs.
Key Responsibilities:
- Serve as the biostatistician in clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time.
- Bring innovative statistical thinking and operational excellence to help drive applications of state-of-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.
About Moderna:
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics and vaccines. We are committed to advancing the field of mRNA science and to bringing innovative treatments to patients worldwide.
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 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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