CMC Statistician

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
  
  

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.

• 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)
  
  

• 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
  
  

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!