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The Role:
This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization. The Senior 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 4+ years or master with 7+ years of relevant working experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.
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 oncology, vaccine/infectious disease and rare disease clinical studies and regulatory interactions are preferred.
Experience working with CROs, vendors, and relationship management.
Experience working with clinical safety, or working as independent unblinded statisticianis 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:
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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