Principal CMC Statistician

Umoja Biopharma•Louisville, CO

18h•Hybrid

About The Position

Umoja Biopharma is an industry-leading biotech 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 our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. 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 experienced Biopharmaceutical Statistician who thrives on turning data into actionable insights. You have proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making as well as supporting CMC Regulatory strategies. You're passionate about using data to accelerate life-saving treatments and expanding their reach to patients who need them most. You 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.

Requirements

Principal Statistician Level: PhD in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 5+ years of experience or equivalent years of work experience
Associate Director Level: 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 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
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.

Nice To Haves

Familiarity with data engineering and basic cloud tools (AWS)
Experience with: Manufacturing statistics (process variability, specification setting, quality metrics)
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
Experience working in biopharmaceutical R&D

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.

Benefits

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume