Principal - Statistician - Product Development Statistics

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

Lilly Research Laboratories (LRL) aims to discover and develop novel medicines that will benefit patients globally through a relentless focus on innovation and solutions to unmet needs. We are looking for a highly qualified statistician to support a wide variety of projects in the product development (nonclinical) area of LRL in collaboration with biologists, chemists, formulators, and engineers. In addition to strong technical skills, the role requires a strong desire and ability to take initiative, educate, and communicate the value of good statistical practices and concepts to a variety of fellow scientists.

Requirements

• M.S. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field with at least 5 years relevant experience.

Nice To Haves

• Additional work experience, especially in the application of statistics in the pharmaceutical development or manufacturing areas.
• Excellent English communication skills, especially related to technical/scientific issues.
• Proficient in R, Python, JMP and/or SAS programming language.
• Proficient in acquiring and compiling data across sources.
• 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.

Responsibilities

• Provide statistical support to scientists in Product Development with a mix of emphasis on a variety of molecule types, including new modalities.
• 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.
• Experimental design and analysis support for analytical chemists to develop, validate, and transfer analytical methods.
• Design and analysis of long-term and accelerated stability studies to inform development of clinical phase and commercial specifications and expiry dating.
• Development and implementation of novel methods to enable or advance drug development and manufacturing.
• Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for successful product approval throughout the world.
• Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, and/or multivariate analysis.
• Collaborate with team members or external partners to communicate development study results with an emphasis on clarity and visualization.
• Assist with or be responsible for communicating via manuscript or oral presentation.
• Communicate results in one-on-one meetings with key customers or external partners and present at scientific meetings.
• Develop understanding of scientific areas and disease states to enhance the level of customer focus and collaboration and be a strong scientific contributor.
• Perform work in full compliance with assigned curricula and follow applicable Corporate, local, and departmental policies, procedures, processes, and training.
• Develop and provide training courses for various statistical methods.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal