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 patientsHere'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 timeChampion 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 programsCollaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data typesOversee development of statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analysesPlan, manage, and track biostatistics activities, timelines, and resources and assure operational excellenceFrequently interact with regulatory agencies and effectively address the statistical questions and requestsReview and/or author SOPs and/or Work Instructions related to biostatistics practicesCollaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goalsOversee statistical contractors / consultants and manage / mentor junior team membersHere'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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince 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 peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.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.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is 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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at ****** . (EEO/AAP Employer) #LI-JL3-
