Principal Statistician - Manufacturing

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

This role is for a Principal Statistician in Manufacturing at Eli Lilly, a global healthcare leader. The primary focus is on applying statistical expertise to support the manufacturing of current and new products and processes. Key responsibilities include designing experiments, establishing control strategies and regulatory specifications, evaluating process capability, and collaborating with cross-functional teams. The role requires a Master's degree in Statistics and at least 3 years of experience in industrial statistics, with a strong preference for CMC experience and proficiency in statistical software.

What you'd actually do

  1. Collaborate with personnel supporting all aspects of manufacturing to provide statistical expertise, study design, and analysis and communicate data driven decisions for process improvements, process understanding, analytical methods, and stability studies.
  2. Establish control strategies for manufacturing processes and analytical assays, evaluate process control and capability, and determine appropriate regulatory specifications.
  3. Communicate statistical concepts and analysis in one-on-one meetings, oral presentations, and internal reports.
  4. Develop a thorough understanding of the process/systems relevant to the manufacture of the active ingredient and/or final drug product.
  5. Serve as the statistical lead and effective member of diverse multi-functional teams providing statistical guidance and problem-solving acuity on a wide range of projects.

Skills

Required

  • Master degree in Statistics
  • 3 years of experience in industrial statistics
  • Statistical expertise
  • Study design
  • Statistical analysis
  • Process improvements
  • Process understanding
  • Analytical methods
  • Stability studies
  • Control strategies
  • Process control
  • Process capability
  • Regulatory specifications
  • Statistical concepts
  • Statistical software (JMP, SAS, R)
  • Experimental Design
  • Regression
  • Six Sigma
  • Statistical Process Control and Improvement
  • Mixed Models
  • Sampling
  • Drug development or manufacturing experience
  • Decision-making
  • Balancing multiple activities
  • Prioritization
  • Managing ambiguity
  • Teamwork
  • Interpersonal skills
  • Problem solving
  • Attention to detail
  • Result oriented behaviors

Nice to have

  • CMC experience

What the JD emphasized

  • Master degree in Statistics
  • At least 3 years of experience in industrial statistics