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Biostatistician, Safety Statistics

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Sep 15, 2022

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Job Details

The Role:

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization. The Biostatistics will be involved in the design, execution, analysis, and reporting of clinical studies and observational safety studies across Modernas programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients.

Heres What Youll Do:

  • Serve as the biostatistician in clinical development teams responsible for part of or entire clinical study biostatistics deliverables with high quality and on time. Develop statistical sections of protocols, statistical analysis plans (SAP), and key specifications for statistical programming implementation of analyses

  • Develop statistical sections of protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses

  • Author Program Safety Assessment Plans (PSAP) and safety data integration in analyzing medical product safety across studies. Collaborate with statistical programmer to implement and ensure all statistical analyses specified in analysis plans are conducted appropriately.

  • Collaborate with epidemiologists to support the development of protocols and execution of Statistical Analysis Plans for post-marketing safety study using real world data (RWD).

  • Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence

  • Responsible to bring operational excellence to help drive applications of state-of-art statistical methods that increase the probability of successes for clinical development programs

  • Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

Heres What Youll Bring to the Table:

  • PhD (or equivalent degree) with major in statistics, biostatistics, data sciences or other quantitative science field. MS degree with 2+ years (MS) or relevant work experience in Biotech, Pharma, Regulatory authorities, or Clinical Research Organizations

  • Understanding of epidemiology or Drug safety and the application of retrospective or prospective observational studies to generate RWE.

  • Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems

  • Good 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 winter shut down
    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.

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 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-MS1

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Company

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.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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