Principal CMC Statistician

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.

CORE ACCOUNTABILITIES 

Specific responsibilities include:

• 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.

The successful candidate will have:

• 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

Preferred Qualifications:  

• 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


• 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

Physical Requirements:  

• 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.

Principal Statistician Salary Range: $152,660 – $188,580

Associate Director Salary Range: $191,420 - $236,460