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 and point-of-contact in multiple clinical development teams responsible for determining clinical study strategies and delivering results with high quality and on time
- Leader to bring innovative statistical thinking and methods to help drive applications of excellent statistical methods that increase the probability of successes for clinical development programs
- Collaborate with internal and external stakeholders to ensure fit-for-purpose quantitative approaches are applied to the collection and analysis of a wide variety of data types
- 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
- Frequently interact with regulatory agencies and effectively address the statistical questions and requests
- Provide 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:
- MS or PhD (or equivalent degree) with 10+ years of relevant work experience in Biotech, Pharma, 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 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.
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.