Director, Biostatistics

The Role:

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Moderna’s development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Here’s What You’ll Do:

• Serve as the biostatistics leader in multiple clinical development teams responsible for determining clinical study strategies and manage teams to deliver results with high quality and on time

• Champion in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs

• Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types

• Oversee development of statistical sections of clinical development plans, 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

• Frequently interact with regulatory agencies and effectively address the statistical questions and requests

• Review and/or author 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

• Oversee statistical contractors / consultants and manage / mentor junior team members

Here’s What You’ll Bring to the Table:

• PhD (or equivalent degree) with 9+ (for Director) of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 12+ years of relevant experience.

• Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems. Experience in Rare Diseases therapeutics clinical development is preferred.

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Experience working on oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred.

• Experience working with clinical safety, independent unblinded statistician is preferred. 

• Experience working with CROs, vendors, and relationship management preferred. 

• 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.

Moderna is pleased to provide you and your family with 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!

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,