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Director, Safety Statistics

Company: Moderna Theraputics
Location: Cambridge
Posted on: June 7, 2021

Job Description:

The Role:

This role is an exciting opportunity to be a critical part of a high growth organization that is radically changing the biotech industry. The Director of Safety Statistics will be involved in the plan, analysis, and reporting safety data across Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Here's What You'll Do:

  • Serve as the statistics leader in leveraging advanced statistical methodologies and overseeing executions on assembling, analyzing, and reporting safety data on multiple products to deliver timely results with high quality

  • Champion in bringing cutting edge methods such as machine learning to analyze big data sets for effective signal detection and reporting

  • 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

  • Participate the development of safety statistical analysis sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of safety statistical analyses

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

  • Frequently interact with regulatory agencies and effectively address the statistical questions and requests

  • 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

Here's What You'll Bring to the Table:

  • PhD (or equivalent degree) with 9+ years 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

  • Familiar with safety data bases used in pharmaceutical / biotechnology industry

  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

  • Extensive experience and excellent skillsets in managing teams and engagement of 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.

Here's What We'll Bring to the Table:

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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 person's 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.

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Keywords: Moderna Theraputics, Cambridge , Director, Safety Statistics, Other , Cambridge, Massachusetts

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