Umoja Biopharma · 10 hours ago
Principal CMC Statistician
Seattle, WA
Full-time
Hybrid
Lead/Staff, Director/Executive
$153K/yr - $189K/yr
5+ years expUmoja Biopharma is an industry-leading biotech focused on transforming cancer treatment with a novel immunotherapy platform. The Principal CMC Statistician will drive statistical strategies for product specifications and regulatory submissions while collaborating with scientists and engineers to optimize manufacturing processes.
BiopharmaBiotechnology
Responsibilities
Drive statistical strategies for establishing process and product specifications, comparability efforts when needed, including contributing to risk assessments, investigations and information requests with potentially direct interface with FDA/EMA statisticians during regulatory reviews
Help drive statistically supported PPQ strategies to validate processes and platforms
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
Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
Collaborate closely with scientists and engineers on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing
Collaborate closely with Research and Clinical data scientists to form harmonized approaches and data management strategies
Adherence to GMP when demanded by the specifics of projects, including timely completion of relevant training as provided by Umoja
Qualification
Required
PhD in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 5+ years of experience or equivalent years of work experience
PhD in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 8+ years of experience or equivalent years of work 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 or closely related industries with an ability to translate between scientific and computational domains
Advanced proficiency in R or Python
Experience building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)
Practical experience with Git workflows
Ability to sit for prolonged periods of time
Ability to work onsite at least 2x per week in our Louisville, CO (ideal), or Seattle, WA location
Preferred
Familiarity with data engineering and basic cloud tools (AWS)
Experience with manufacturing statistics (process variability, specification setting, quality metrics)
Experience with omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)
Experience with AI/ML application development
Familiarity with immunology and immune cell biology
Working understanding of molecular mechanisms in cancer and cell therapy
Experience working in biopharmaceutical R&D
Ability to self-motivate to identify high-impact initiatives and drive them to completion
Thrives in multidisciplinary teams while independently determining what needs to be done
Proactively identifies opportunities to improve and expedite projects and workflows
Benefits
Competitive Medical, Dental, and Vision plans
401k plan through Fidelity, with a 100% match up to their first 4% deferral
Generous Paid Time Off policy
Employee commuter benefits
Cell phone stipend
Company
Umoja Biopharma
Umoja Biopharma is a biopharmaceutical company developing next-generation immunotherapies intended to combat cancer.
51-200 employees
H1B Sponsorship
Umoja Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
$363MKey Investors
DCVC Bio
2025-01-14Series C· $100M
2021-06-15Series B· $210M
2020-11-18Series A· $53M
Leadership Team
Ryan Crisman
Co-Founder and Chief Technology Officer
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-08
Company data provided by crunchbase