Principal Statistician - Manufacturing
Eli Lilly and Company
9 days ago
Remote friendly (Indianapolis, IN)
United States
Operations
Responsibilities
- Collaborate with manufacturing teams to provide statistical expertise, study design, analysis, and data-driven decisions for process improvements, process understanding, analytical methods, and stability studies.
- Establish control strategies for manufacturing processes and analytical assays; evaluate process control and capability; determine appropriate regulatory specifications.
- Communicate statistical concepts and analysis via 1:1 meetings, oral presentations, and internal reports.
- Develop a thorough understanding of systems relevant to manufacturing the active ingredient and/or final drug product.
- Serve as statistical lead and an effective member of diverse cross-functional teams, providing statistical guidance and problem-solving.
- Apply strong interpersonal skills and work effectively on teams.
Basic Requirements
- Master’s degree in Statistics.
- At least 3 years of experience in industrial statistics.
Additional Skills/Preferences
- CMC experience highly preferred.
- Proficiency in statistical software (e.g., JMP, SAS, R).
- Coursework in Experimental Design, Regression, Six Sigma, Statistical Process Control and Improvement, Mixed Models, Sampling.
- Excellent verbal and written communication skills.
- Experience in drug development or manufacturing.
- Ability to engage in and facilitate decision-making.
- Ability to manage ambiguity, prioritize multiple activities.
- Exemplary teamwork/interpersonal skills; strong problem-solving and attention to detail in a fast-paced environment.
Compensation/Benefits
- Anticipated wage: $112,500 - $193,600.
- Eligible for a company bonus (depending on company and individual performance) and a comprehensive benefits program (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).
- Collaborate with manufacturing teams to provide statistical expertise, study design, analysis, and data-driven decisions for process improvements, process understanding, analytical methods, and stability studies.
- Establish control strategies for manufacturing processes and analytical assays; evaluate process control and capability; determine appropriate regulatory specifications.
- Communicate statistical concepts and analysis via 1:1 meetings, oral presentations, and internal reports.
- Develop a thorough understanding of systems relevant to manufacturing the active ingredient and/or final drug product.
- Serve as statistical lead and an effective member of diverse cross-functional teams, providing statistical guidance and problem-solving.
- Apply strong interpersonal skills and work effectively on teams.
Basic Requirements
- Master’s degree in Statistics.
- At least 3 years of experience in industrial statistics.
Additional Skills/Preferences
- CMC experience highly preferred.
- Proficiency in statistical software (e.g., JMP, SAS, R).
- Coursework in Experimental Design, Regression, Six Sigma, Statistical Process Control and Improvement, Mixed Models, Sampling.
- Excellent verbal and written communication skills.
- Experience in drug development or manufacturing.
- Ability to engage in and facilitate decision-making.
- Ability to manage ambiguity, prioritize multiple activities.
- Exemplary teamwork/interpersonal skills; strong problem-solving and attention to detail in a fast-paced environment.
Compensation/Benefits
- Anticipated wage: $112,500 - $193,600.
- Eligible for a company bonus (depending on company and individual performance) and a comprehensive benefits program (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).