Sr. Director, Preclinical Statistics
- Moderna, Inc.
- Cambridge, MA
- Start date
- Mar 18, 2023
- Science/R&D, Biostatistics
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Genetown, Best Places to Work
This role is an exciting opportunity to be a critical part of the development group of a high growth organization that is radically changing the biotech industry. The Sr. Director of Preclinical Statistics will be involved in the analysis and reporting broad range of assay development data including qualification, validation, and correlation etc. across Modernas development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients
Heres What Youll Do:
Develop biostatistics strategy on biomarker assay development focusing on quantitative data analyses, leveraging data to accelerate the development, qualification, and verification of biomarker assays across portfolio
Serve as the biostatistics leader and point-of-contact on assay planning and analyses in multiple clinical development teams responsible for determining assay development statistics strategies and delivering results with high quality and on time
Serve as the Subject Matter Expert (SME) for effective interactions with global regulatory agencies regarding statistical requirements of assay development, data analyses, interpretation of quantitative data, and addressing regulatory questions
Leader in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the efficiency and effectiveness for biomarker assay development and leveraging biomarker data to inform critical decision makings
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 on assay development
Oversee development of the statistical analysis plans related to assay development data, and key specifications for statistical programming implementation of analyses
Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence
Review and/or author SOPs and/or Work Instructions related to assay development statistics 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
Heres What Youll Bring to the Table:
PhD with 12+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 15+ years of relevant experience.
Excellent strategic thinking on innovative statistical methods and proficiency in commonly used statistical models and data analyses methods on biomarker assay development
Operational excellence mindset 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 and overseeing 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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
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 www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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.#LI-AK1
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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