Advisor

About the Role

Lilly Research Laboratories (LRL) is seeking a highly qualified statistician to support various projects within the product development (nonclinical) area. This role involves collaboration with biologists, chemists, formulators, and engineers. The statistician will be expected to take initiative, educate, and communicate the value of statistical practices to fellow scientists.

Key Responsibilities

• Provide statistical support to Product Development scientists, focusing on diverse molecule types, including new modalities.
• Offer experimental design and analysis support for chemists, biologists, and formulation scientists to develop and optimize chemical/biochemical processes, as well as oral and parenteral formulations in both batch and continuous manufacturing.
• Provide experimental design and analysis support for analytical chemists in the development, validation, and transfer of analytical methods.
• Design and analyze long-term and accelerated stability studies to inform the development of clinical phase and commercial specifications and expiry dating.
• Develop and implement novel methods to enable or advance drug development and manufacturing.
• Author sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents.
• Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, and/or multivariate analysis.

Communication

• 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.

Therapeutic/Scientific Area Knowledge

• Develop an understanding of scientific areas and disease states to enhance customer focus, collaboration, and scientific contribution.

Regulatory Compliance

• Perform work in full compliance with assigned curricula and applicable Corporate, local, and departmental policies, procedures, processes, and training.

Training and Development

• Develop and provide training courses for various statistical methods.

Requirements & Tech Stack

• 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 of relevant experience.
• R, Python, JMP, and/or SAS programming language proficiency.
• Proficiency in acquiring and compiling data across sources.
• Expertise in DOE, Bayesian, machine learning, and visualization.
• Excellent English communication skills, particularly related to technical/scientific issues.
• Interpersonal/teamwork and communications skills for effective customer collaboration.
• Strong teamwork and leadership skills.
• Self-management skills, creativity, and innovation.
• Demonstrated problem-solving ability and strategic thinking.
• Degree in or strong desire to learn about chemistry, biology, engineering, computer science, and pharmaceutical science.
• Additional work experience, especially in the application of statistics in the pharmaceutical development or manufacturing areas, is preferred.