Senior CMC Data Scientist

We have a current opportunity for a Senior CMC Data Scientist on a permanent basis. The position will be based in Colorado. For further information about this position please apply.

Position Summary

We are seeking a seasoned Senior CMC Data Scientist with a passion for transforming complex data into actionable insights that accelerate life-saving therapies. This individual will bring deep statistical expertise across Analytical Development and Quality, playing a pivotal role in CMC decision-making. The ideal candidate thrives in fast-paced environments, excels at building reproducible data products, and is driven by the mission to expand access to critical treatments in Car T Cell Therapies.

Core Accountabilities

Key responsibilities include:

• Statistical Strategy & Regulatory Engagement
  Develop and lead statistical strategies for process validation and comparability, including risk-based PPQ approaches. Serve as a direct interface with FDA/EMA statisticians during regulatory reviews.

• Study Design & Process Optimization
  Design and analyze statistically robust studies to optimize manufacturing processes, define control strategies, and support regulatory submissions in alignment with ICH/FDA/EMA guidance.

• Data Product Development
  Build and maintain reproducible data science products-such as interactive dashboards and analytic reports-that effectively communicate complex findings to diverse stakeholders.

• Collaborative Coding Practices
  Work within Git-based workflows for version control and collaborative code development.

• Scientific-Computational Translation
  Translate scientific questions into computational solutions by applying appropriate statistical models and methods.

• Cross-Functional Collaboration
  Partner with scientists across disciplines including immunology, molecular biology, process development, and manufacturing.

• GMP Compliance
  Adhere to GMP requirements as dictated by project needs, including timely completion of relevant training provided by Umoja.

Qualifications

Required:

• PhD (2+ years) or MS (5+ years) in Statistics, Biostatistics, Computer Science, Bioinformatics, or a related computational field.
• Strong foundation in applied statistics, modeling, and method selection.
• Proven experience solving computational problems in scientific research settings.
• Demonstrated ability to develop analysis pipelines and reports.
• Experience collaborating in therapeutic development, with fluency in both scientific and computational domains.
• Expertise in manufacturing statistics (e.g., process variability, specification setting, quality metrics).
• Advanced proficiency in R or Python.
• Practical experience with Git workflows.

Preferred:

• Familiarity with data engineering and cloud platforms (e.g., AWS).
• Experience with:
  • Interactive dashboard/report development (e.g., R Markdown, Jupyter, Shiny, Dash, Streamlit).
  • Omics assays (e.g., transcriptomics, proteomics, single-cell analysis, flow cytometry).
  • AI/ML application development.
• Background in immunology and immune cell biology.
• Understanding of molecular mechanisms in cancer and cell therapy.
• Prior experience in biopharmaceutical R&D.
• Self-motivated with a track record of identifying and executing high-impact initiatives.
• Comfortable working independently while thriving in multidisciplinary teams.
• Proactive in improving workflows and accelerating project timelines.