CMC Statistician Job at iO Associates - UK/EU, Waltham, MA

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  • iO Associates - UK/EU
  • Waltham, MA

Job Description

CMC Statistician - Biotech/Pharma


Employment Type: Contract or Permanent

Location: Boston (USA-based candidates only)

Compensation:

  • Contract: $120-$200/hour (DOE)
  • Permanent: $140,000-$180,000 base + benefits + bonus

About the Opportunity


iO Associates is supporting a growing biopharmaceutical company focused on the development of complex therapeutics requiring advanced Chemistry, Manufacturing, and Controls (CMC) strategies. As part of their continued expansion, they are seeking a candidate to lead/support in the design and analysis of analytical, manufacturing, and stability studies.

Key Responsibilities

  • Statistical design and analysis for CMC-related studies, including:
    • Method validation
    • Stability studies (e.g., shelf-life estimation, degradation modelling)
    • Process validation and comparability
  • Provide statistical input for regulatory submissions (IND, NDA, BLA)
  • Support & partner with cross-functional teams to design DOE (Design of Experiments) and implement QbD (Quality by Design) strategies
  • Perform statistical analysis using tools such as SAS, R, JMP, or Minitab
  • Present findings to both technical and non-technical stakeholders
  • Support responses to regulatory queries from agencies (e.g., FDA, EMA)

Ideal Candidate Background

  • MSc or PhD in Statistics, Biostatistics, or related quantitative field
  • 5+ years of experience in pharmaceutical, biotech, or medical device industries
  • Solid working knowledge of:
    • FDA and ICH guidelines (Q2, Q6A, Q8, Q9, Q10, Q14)
    • Method validation and transfer
    • Statistical techniques such as ANOVA, regression, multivariate analysis, control charts
  • Familiarity with regulatory submission processes and statistical content requirements
  • Experience working in a GxP environment

Who You Might Have Worked For


Candidates may come from:

  • Small-Mid-sized biotech and pharmaceutical companies
  • Contract Research or Manufacturing Organizations (CROs/CMOs)
  • Regulatory consulting firms or statistical service providers

Drop me a call if you'd like to explore this opportunity more!

Job Tags

Permanent employment, Contract work,

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