Research Scientist - Statistics - Product Development

Lilly is a global health care leader that unites caring with discovery to make life better for people around the world. For more than a century, we have stayed true to a core set of values-excellence, integrity, and respect for people-that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities. We also are committed to investing in our employees and supporting a culture of well-being -through competitive pay, comprehensive employee benefit programs, and training and development resources.

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Responsibilities
The statistician will provide statistical support to scientists in Product Development with a mix of emphasis on both small molecule and large molecule product development.

• Experimental design and analysis support for chemists/biologists and formulation scientists to develop & optimize chemical/biochemical processes as well as 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 regulatory (CM&C - Chemistry, Manufacturing and Control) 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.

Training and Development

• Develop and provide training courses for various statistical methods

Communication of Results

• Collaborate with team members or external partners to communicate development study results with an emphasis on visualization
• Assist with or be responsible for communicating study results via manuscript or oral presentation
• Communicate results in one-on-one meetings with key customers or external partners and present at scientific and therapeutically focused meetings

Therapeutic/Scientific Area Knowledge

• Understand disease states and scientific areas in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor

Regulatory Compliance

• Perform work in full compliance with assigned curricula and will be responsible for following applicable Corporate, local, and departmental policies, procedures, processes, and training

45558BR

Basic Qualifications

• PhD in Statistics, Biostatistics, Operations Research, or related field
• OR M.S. in Statistics, Biostatistics, Operations Research, or related field with at least 5 years industrial experience

Additional Skills/Preferences

• Additional work experience, especially in the application of statistics in the pharmaceutical development or manufacturing areas, would be of value
• Proficient in R, Python, JMP and/or SAS programming language, data acquisition and compilation across sources
• Expertise in DOE, Bayesian, machine learning, visualization
• Interpersonal/teamwork and communications skills for effective customer collaboration
• Strong teamwork and leadership skills with future interest in supervising other statisticians
• Self-management skills, creativity, and innovation.
• Demonstrated problem solving ability and strategic thinking
• Strong desire to learn about chemistry, biology, engineering, and pharmaceutical science

Additional Information

• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status