Senior CMC Biostatistician

Job Description

Senior CMC Data Scientist/Statistician
This role can be located in the Denver metro area or Seattle WA
Salary Range: $142630 - $176190 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

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