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!