Project Statistician - Manufacturing

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.

Organization Overview:

Our Global Statistical Sciences department includes over 200 people with advanced degrees in Statistics/Biostatistics. Our diverse population of global talent brings innovation to every aspect of our business - from Discovery Research to Clinical Development to Manufacturing and Real-world Evidence. We are playing a leading role in transforming the way the company develops medicines using state-of-the-art methods in adaptive designs, Bayesian statistics, causal inference, regression, visualization and more!

Responsibilities:

A Project Statistician – Manufacturing supports the manufacture of 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, regression, establishment of regulatory specifications, establishment of control strategies and evaluation of capability.

• Collaborate with personnel supporting all aspects of manufacturing to provide statistical expertise, study design, and analysis and communicate 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, and determine appropriate regulatory specifications.

• Communicate statistical concepts and analysis in one-on-one meetings, oral presentations, and internal reports.

• Develop a thorough understanding of the process/systems relevant to the manufacture of the active ingredient and/or final drug product.

• 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.

Basic Requirements:

• Minimum of a MS degree in Statistics.

Additional Skills/Preferences:

• Proficiency in the use of statistical software (e.g. JMP, SAS, R, etc.).

• Coursework (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 balance multiple activities, prioritize and manage ambiguity.

• Demonstrated exemplary teamwork/interpersonal skills.

• Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.

Additional Information:

• Shift: Monday–Friday, flex time observed

• Location: Indianapolis, Indiana or Research Triangle Park, North Carolina

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadershi