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 work model.

Category
Biology Lab & Research
Biology & Biotech
Required Skills
R
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
  • Demonstrated leadership experience, including managing and mentoring a team of statisticians, with the ability to inspire and develop a high-performing team
  • Proven track record of leading and delivering complex statistical projects in a fast-paced, dynamic environment
  • Strong collaborative skills, with a demonstrated ability to work effectively with cross-functional teams and senior management
  • Exceptional communication skills, capable of conveying complex statistical concepts to non-statistical audiences
  • Demonstrated ability to innovate and drive continuous improvement in statistical practices and methodologies
  • Mastery of statistical methods such as Design of Experiments (DOE), regression modeling, variance component analysis, multivariate analysis, process capability, and control charts
  • Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background
  • Thorough comprehension of regulatory guidance, including ICH, WHO, USP guidelines
  • Experience in regulatory interactions and submissions, including eCTD submissions, response to health authority questions, and agency meetings
  • Skilled in teaching non-statisticians basic & intermediate statistical methods
  • Advanced skills using one or more statistical packages or languages (e.g., JMP, SAS, or R)
  • Proficiency with Microsoft Office suite (i.e. Word, Excel, PowerPoint)
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.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
Simplify Jobs

Simplify's Take

What believers are saying

  • Opening a new vaccine facility in Victoria enhances manufacturing capabilities.
  • Strategic investment in China boosts Moderna's presence in the Asian market.
  • Collaboration with Carisma Therapeutics could lead to breakthroughs in autoimmune treatments.

What critics are saying

  • Potential removal from Nasdaq 100 could impact investor perception.
  • Reticence in Hong Kong for Covid-19 jab indicates market penetration challenges.
  • Expansion into China may expose Moderna to geopolitical and regulatory risks.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for innovative medical treatments.
  • The company has a strong focus on developing vaccines for infectious diseases.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

Help us improve and share your feedback! Did you find this helpful?