Senior CMC Biostatistician

Senior CMC Data Scientist/Statistician
This role can be located in the Denver metro area, or Seattle, WA
Salary Range: $142,630 - $176,190 + bonus + benefits

Our client is a game-changing biotech start-up focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. They were named one of the Most Promising Biotech Companies in 2025, have 6 programs in the clinic moving into Phase I (one has been fast-tracked) and also have their own manufacturing facility. This client is made up of a diverse and growing team and they are looking for innovative thinkers who are excited by groundbreaking science and technology. Currently they have a specific need for a Biopharmaceutical Data Scientist who thrives on turning data into actionable insights. The ideal candidate has proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making. They excel at building reproducible data products and drive impact autonomously in a fast-paced environment.

• Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews
• Lead statistically robust study design and analysis to optimize manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance
• Build and maintain reproducible data science communication products including interactive dashboards, analytic reports, and other deliverables that effectively communicate complex findings to diverse stakeholders
• Collaborate using Git workflows for version control and code management
• Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
• Collaborate closely with scientists on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing

If you have:

• PhD or MS in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 2+ years (PhD) or 5+ years (MS) of industry experience
• Strong foundation in applied statistics, statistical modeling, and method selection
• Demonstrated experience in computational problem-solving within a scientific research setting
• Track record of developing analysis pipelines and reports
• Experience in scientific collaborations within therapeutics development with an ability to translate between scientific and computational domains
• Experience with manufacturing statistics (process variability, specification setting, quality metrics)
• Advanced proficiency in R or Python
• Practical experience with Git workflows
• Familiarity with data engineering and basic cloud tools (AWS)
• Experience with building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)
• Experience with Omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)
• AI/ML application development
• Familiarity with immunology and immune cell biology
• Working understanding of molecular mechanisms in cancer and cell therapy

 Please reach out at

sdevine@penfieldsearch.com