Principal - Statistician - Product Development Statistics

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

This role provides statistical support for drug development in a healthcare setting, focusing on experimental design, analysis, and the development of novel methods. It involves collaboration with scientists and engineers across various disciplines, including chemistry and biology, and requires expertise in statistical software and methodologies. The role also involves communicating results, contributing to regulatory submissions, and potentially developing training materials.

What you'd actually do

  1. Experimental design and analysis support for chemists/biologists and formulation scientists to develop & optimize chemical/biochemical processes as well as oral and parenteral formulations, in both batch and continuous manufacturing
  2. Experimental design and analysis support for analytical chemists to develop, validate, and transfer analytical methods
  3. Design and analysis of long-term and accelerated stability studies to inform development of clinical phase and commercial specifications and expiry dating
  4. Development and implementation of novel methods to enable or advance drug development and manufacturing
  5. Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for successful product approval throughout the world

Skills

Required

  • M.S. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field
  • at least 5 years relevant experience
  • Excellent English communication skills, especially related to technical/scientific issues
  • Proficient in acquiring and compiling data across sources

Nice to have

  • Additional work experience, especially in the application of statistics in the pharmaceutical development or manufacturing areas
  • Proficient in R, Python, JMP and/or SAS programming language.
  • Expertise in DOE, Bayesian, machine learning, visualization
  • Interpersonal/teamwork and communications skills for effective customer collaboration
  • Strong teamwork and leadership skills
  • Self-management skills, creativity, and innovation
  • Demonstrated exemplary teamwork/interpersonal skills
  • Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
  • Degree in or strong desire to learn about chemistry, biology, engineering, computer science, and pharmaceutical science

What the JD emphasized

  • strong technical skills
  • strong desire and ability to take initiative, educate, and communicate the value of good statistical practices and concepts to a variety of fellow scientists
  • strong scientific contributor
  • Perform work in full compliance with assigned curricula and follow applicable Corporate, local, and departmental policies, procedures, processes, and training.