Full-Time

Principal Statistician

CMC Quantitative Sciences

Posted on 10/2/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Norwood, MA, USA

70% in-office work model.

Category
Computational Biology
Biology Lab & Research
Biology & Biotech
Required Skills
R
Data Analysis
Requirements
  • PhD in Statistics or related discipline with 5 - 8 years of relevant experience; MS degree in Statistics or related discipline with 8 - 10 years of relevant experience; or BS degree in Statistics or related discipline with 10 - 15 years of relevant experience
  • 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
  • Advanced skills using one or more statistical packages or languages (e.g., JMP, SAS, or R)
  • Ability to instruct non-statisticians in basic & intermediate statistical methods
  • Exceptional communication skills, both verbal and written
  • Proficiency with Microsoft Office suite (i.e. Word, Excel, PowerPoint)
  • Familiarity with GMP quality concepts used in pharmaceutical production and development
  • Regulatory writing experience, including eCTD submissions and response to health authority questions
  • Thorough comprehension of regulatory guidance, including ICH, WHO, USP guidelines
  • Experience with phase appropriate GMP principles
  • Understanding of risk analysis and risk-based decision making
  • Skilled at balancing practical importance, business impact, and scientific rigor associated with decisions
  • Strong collaborative skills in a cross-functional matrix organizational structure
  • Capable of managing multiple projects in a dynamic environment
  • Detail-oriented with a passion for science and data analysis
  • Self-motivated with outstanding communication skills
  • Keen to learn & adapt, with the ability to pivot in the face of new data
Responsibilities
  • Serve as strategic partner to product teams, providing project-specific support on justification of specifications, shelf-life analysis, comparability assessments, and investigational analysis
  • Provide consultation to internal stakeholders, appropriately addressing research questions by designing proper experiments & matching correct statistical tools to requests
  • Collaborate with scientists, engineers, and other statisticians to facilitate data-driven decision making, fostering a common understanding of statistical principles and interpretation of analysis conclusions
  • Clearly articulate complex analysis methodology & findings to a diverse audience, including non-statistician partners, stakeholders, and senior management
  • Embed statistical thinking throughout the organization by educating scientists on statistical tools and their application
  • Contribute to regulatory filings by authoring & reviewing statistical content in module 3 of IND, IMPD, BLA, and MAA dossiers
  • Act as subject matter expert for statistical aspects of the analytical method lifecycle, including method development, qualification, validation, and investigations
  • Strongly partner with process development teams to enhance our platform by applying Quality by Design principles to process characterization and process change activities
  • Set, maintain, and model best statistical practices to drive consistency across CMC statistics and Moderna’s platform
  • Mentor junior team members & act as key advisor to scientist partners
  • Continue to advance & share your knowledge of relevant CMC topics through literature, training, & conference attendance
  • Potential to act as Team Lead 2 within Moderna’s Team Leads model: team leader is responsible for tactical management of daily activities of small team of CMC statisticians
  • Additional duties as may be assigned from time to time

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 chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to harness the power of mRNA to improve patient outcomes and create effective treatments for a range of diseases.

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%
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Simplify's Take

What believers are saying

  • mRNA technology is expanding into personalized cancer vaccines, revolutionizing treatment.
  • Recent advancements in lipid nanoparticle delivery enhance mRNA vaccine efficacy.
  • Global mRNA vaccine market projected to grow significantly, boosting Moderna's prospects.

What critics are saying

  • Potential exclusion from Nasdaq 100 could impact investor perception and liquidity.
  • Bypassing safety steps in Australia may raise regulatory scrutiny.
  • Geopolitical tensions in China pose operational and financial risks for Moderna.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company has developed one of the earliest and most effective COVID-19 vaccines.
  • Moderna's mRNA platform enables rapid development of vaccines for various diseases.

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