Advisor - Project Statistician in Product Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Brand

Description:

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.

Location:

Indianapolis

• The statistician will 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.

• Ph.D. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field or M.S. in Statistics, Biostatistics, Industrial Engineering, Operations Research, or related field with at least 8 years relevant experience.

• 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…