This role will support Manufacturing for current and new products and processes, driving and sustaining statistical thinking and appropriate use of statistical methodologies. Specific aspects include (but not limited to) statistically designed experiments, sampling, stability, packaging, establishment of regulatory specifications, evaluation of control/capability, process/analytical method validation/transfers and developing.
https://lilly.wd5.myworkdayjobs.com/CMP/job/Project-Statistician—Manufacturing_R-55506
Key Objectives
- Provide statistical expertise, study design, and analysis and communicate data driven decisions for process improvements, process understanding, method development and validation, assay transfer, and stability studies in collaboration with personnel supporting all aspects of manufacturing.
- Establish control strategies for manufacturing processes and analytical assays, evaluate process control and capability, and determine appropriate regulatory and release specifications.
- Maintain statistical expertise by learning new methodologies, choosing which methods to use in analysis, and justifying methods selected.
- Communicate study results and statistical concepts in one-on-one meetings, oral presentations, internal reports, and presentations at professional association meetings.
- Develop and administer training courses for various statistical methods and software, including planning and leading workshops to help facilitate statistical thinking across the various functional areas.
- Demonstrate a thorough understanding of the process/systems relevant to the manufacture of drug products.
- Serve as the statistical lead and effective member of diverse multi-functional teams providing statistical guidance and problem-solving acuity on a wide range of projects.
- Strong interpersonal skills (job requires significant customer/peer/management interaction) and ability to work effectively on teams.
Requirements:
- Currently enrolled in and attending graduate school and will complete a MS degree in Statistics OR a related field.