Description:
This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization. The Manager of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies in Moderna’s clinical programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients.
Here’s What You’ll Do:
- 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-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
Here’s What You’ll Bring to the Table:
- PhD in statistics (or equivalent degree) with 2+ years or master with 5+ years of relevant working experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. Experiences working in oncology, vaccine/infectious disease, and rare disease is preferred.
- Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems
- Working knowledge of relevant ICH guidelines, US, EU and other regions’ 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.
- This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.