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Full-Time

Director – CMC Quantitative Sciences

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior, Expert

Norwood, MA, USA

70% in-office structure.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • PhD in Statistics or related discipline with 10+ years of relevant experience; MS degree in Statistics or related discipline with 10 - 15 years of relevant experience; or BS degree in Statistics or related discipline with 15+ years of relevant experience
  • Minimum of 5 years in direct team leadership role
Responsibilities
  • Develop and implement advanced statistical methodologies to support the company's strategic goals.
  • Provide high-level statistical consultation and direction to senior management and cross-functional teams, influencing key business decisions.
  • Drive the design and execution of complex experimental designs and statistical models to address multifaceted research questions.
  • Lead and manage the CMC Statistics team, overseeing the work of junior and senior statisticians.
  • Foster a culture of statistical excellence and continuous learning within the team.
  • Provide mentorship and professional development opportunities for team members.
  • Build a high performing team, including delivering feedback, evaluating team member performance, & evaluating potential candidates.
  • Oversee multiple high-impact projects, ensuring timely and effective delivery of statistical analyses and reports.
  • Collaborate with cross-functional leaders to align statistical strategies with overall project and company objectives.
  • Serve as the senior statistical expert on critical projects, guiding the application of sophisticated statistical techniques to our most complex and challenging problems.
  • Apply technical expertise to individual analysis methodology, guiding decisions that balance technical detail, simplicity, and business needs
  • Partner with leaders in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research to integrate statistical principles into all phases of product development and production.
  • Champion data-driven decision-making processes, ensuring robust statistical frameworks are embedded in project plans and research initiatives.
  • Stay abreast of the latest advancements in statistical science, biostatistics, and regulatory guidelines to ensure the team remains at the cutting edge of the field.
  • Identify and implement new statistical tools and software to enhance the efficiency and effectiveness of the CMC Statistics team and the CMC Quantitative Sciences team on the whole.
  • Lead initiatives to streamline statistical processes, reducing development timelines and improving the quality of our biotechnological innovations.
  • Ensure compliance with regulatory requirements and industry standards for statistical practices, providing expert guidance during regulatory submissions and audits.
  • Represent the company in interactions with regulatory agencies, effectively communicating statistical methodologies and findings, including in CTD sections, responses to questions, and meetings with agencies
  • Additional duties as may be assigned from time to time

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

8%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.