Senior CMC Biostatistician

Penfield Search Partners•Seattle, WA

1d•$142,630 - $176,190

About The Position

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 are a diverse and growing team looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. 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.

Requirements

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.)

Nice To Haves

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

Responsibilities

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