Advisor - Statistician in Product Development

Eli Lilly and Company; Indianapolis (IN); On-site; USD 120,000 - 165,000; Full time

Job summary

Eli Lilly and Company is seeking a statistician to provide statistical support to scientists in Product Development, including diverse molecule types and new modalities. You will design experiments, analyze data, and contribute to formulation and process development, with emphasis on DOE, Bayesian, and machine learning.

The role involves collaboration with chemists, biologists, and analytical scientists, development of novel methods, and authoring CMC regulatory documentation for global

Qualifications

• Ph.D. or MS in statistics or related field with pharmaceutical experience preferred
• Additional work experience in pharmaceutical development or manufacturing is desirable
• Excellent English communication skills, especially technical/scientific issues
• Proficiency in acquiring and compiling data from multiple sources
• Expertise in DOE, Bayesian, machine learning, visualization
• Interpersonal/teamwork and communications for customer collaboration
• Strong teamwork and leadership skills
• Self-management, creativity and innovation
• Demonstrated teamwork/interpersonal skills and problem solving in fast-paced environments
• Degree in or interest in chemistry, biology, engineering, computer science, or pharmaceutical science

Responsibilities

• Provide experimental design and analysis support for chemical/biochemical processes and formulations (batch and continuous)
• Support analytical chemists to develop, validate, and transfer analytical methods
• Design and analyze long-term and accelerated stability studies for clinical specs and expiry dating
• Develop and implement novel statistical methods to advance drug development and manufacturing
• Author CMC regulatory submission sections for product approvals worldwide
• Collaborate on applied research projects involving modeling, experimental design, process control, and multivariate analysis
• Communicate results with clarity and visualization to team members and external partners
• Assist with manuscripts or oral presentations of study results
• Communicate results in one-on-one meetings with customers and at scientific meetings
• Develop understanding of scientific areas to enhance collaboration and customer focus
• Perform work in compliance with policies, procedures, and training
• Develop and provide training courses for statistical methods

Skills

R, Python, JMP, SAS

DOE

Bayesian methods

Machine learning

Data visualization

Scientific communication

English communication

Statistical design

Education

PhD in Statistics/Biostatistics/Industrial Engineering/Operations Research

MS in Statistics/Biostatistics/Industrial Engineering/Operations Research with 10+ years pharma

Tools

R

Python

JMP

SAS

Job description

Key Objectives/Deliverables:

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.

Communicate Results

• 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 understanding of scientific areas and disease states to enhance the level of customer focus and collaboration and be a strong scientific contributor.

Regulatory Compliance

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

Training and Development

• Develop and provide training courses for various statistical methods

Requirements:

• Ph.D. in Statistics, Biostatistics, Industrial Engineering, Operations Research

or

• S. in Statistics, Biostatistics, Industrial Engineering, Operations Research with at least 10 years pharmaceutical experience

Additional Skills/Preferences:

• 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [e-mail] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.