This job has expired

You will need to login before you can apply for a job.

Sr. Manager, Safety Statistics

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Aug 5, 2022

View more

You need to sign in or create an account to save a job.

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 that is radically changing the biotech industry. The Sr. Manager of Safety Statistics will be involved in the plan, analysis, and reporting safety data across Modernas development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Heres What Youll Do:

  • Serve as the biostatistics leader and point-of-contact for one or more clinical development programs. Lead and develop safety statistical strategy for the clinical program development and regulatory submission.

  • Provide statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions.

  • Author the Integrated Safety Statistical Analysis Plans and lead the development of safety data integration specifications in accordance with analysis plan.

  • Represent function/department on product safety and risk management team to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, or Pharmacovigilance) to create development strategies for assigned projects. Build interdepartmental relationships.

  • Support interactions with regulatory agencies and effectively address the statistical questions and requests regarding investigational products safety in clinical development.

  • Collaborate with Epidemiologists to develop Statistical Analysis Plans for post-marketing safety studies.

  • 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

Heres What Youll Bring to the Table:

  • PhD (or equivalent degree) with 3+ of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 6 of relevant experience.

  • 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.

  • Some prior experience supporting safety-related projects is preferred (e.g., ISS, benefit-risk assessment, signal detection, observational study)

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

-

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

 

Facebook  Instagram  Twitter

 

Find Us
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert