Senior CMC Data Scientist / Statistician

Job Description

Job Description

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are 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. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

POSITION SUMMARY

We are hiring for an experienced 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're passionate about using data to accelerate life-saving treatments and expanding their reach to patients who need them most. They excel at building reproducible data products and drive impact autonomously in a fast-paced environment.

This role is based out of our Louisville, CO location, although, exceptional candidates based in Seattle, WA may be considered.

CORE ACCOUNTABILITIES

Specific responsibilities include :

• 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
• Adherence to GMP when demanded by the specifics of projects, including timely completion of relevant training as provided by Umoja.

The successful candidate will have :

Preferred Qualifications :

Building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)

Physical Requirements :

Salary Range : $142,630 - $176,190

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.