At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Statistician supports TS/MS 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 specs, evaluation of control/capability, process/analytical method validation/transfers and developing and providing Statistical training.

EDUCATIONAL/EXPERIENCE REQUIREMENTS:

• MSc in Statistics with >3 years’ experience or equivalent
• Proficiency in the use of statistical software (eg: JMP, SAS, R, S-Plus, etc.)
• Prior experience in a pharmaceutical manufacturing environment is preferable.

PRIMARY RESPONSIBILITIES:

• Apply analytical and statistical methodology, including the concepts of Statistical Process Control (SPC), to process and experimental data to identify trends, assess process capability, and provide appropriate conclusions to enable data driven decision-making and to determine the root cause of process upsets.
• 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. Use appropriate statistical methodologies to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews.
• Maintain statistical expertise by learning new methodologies, choosing which methods to use in analysis, and justifying methods selected.
• Use of statistical and programming software (e.g. SAS, R, JMP, Python, SIMCA) to apply a broad range of data science and statistical applications, such as linear regression, DoE, multivariate analysis, and statistical modelling.
• 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.
• Communicate study results and statistical concepts in one-on-one meetings, oral presentations, internal reports, and presentations at professional association meetings.
• Work in a highly fluid environment with rapidly changing priorities providing statistical guidance and problem-solving acumen to diverse teams.
• Ensure data integrity by performing rigorous error checking, and data validation.

ATTRIBUTES FOR THE ROLE:

• A demonstrated interest in the field of statistics
• Skilled in quantitative analysis and data management
• Strong problem solving skills
• Demonstratable learning agility
• Strong ability to influence

ADDITIONAL EXPERIENCE AND ROLE INFORMATION:

• Experience with preparation of regulatory documents and responses to questions from regulatory agencies.
• Knowledge of pharmaceutical process steps such as biologics manufacturing, small molecule organic synthesis, and oral solid dosage form manufacturing is advantageous.
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