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Project Statistician

Indianapolis, Indiana

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Req ID R-1431 Title Project Statistician City Indianapolis State / Province Indiana Country United States

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 39,000 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.

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 39,000 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. #WeAreLilly

Key Objectives/Deliverables

  • 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 cross functional teams providing statistical guidance and problem-solving acumen 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 or related field.

Additional Preferences:

  • Excellent problem solving skills.
  • Strong interpersonal skills (job requires significant customer/peer/management interaction).
  • Excellent verbal and written communication skills.
  • Ability to participate in and facilitate decision-making.
  • Proficiency in the use of statistical software (eg: JMP, SAS, R, S-Plus, etc.). Experience with preparation of regulatory documents such as, but not limited to, sBLAs, BLSs, INDs, Briefing Documents, and responses to questions from regulatory agencies.
  • Coursework (Experimental Design, Regression, Engineering, Six Sigma, Statistical Process Control and Improvement, Mixed Models, Bioassay, Sampling).
  • M.S. with 3-5 years industry experience or Ph. D. in Statistics or related field.
  • Experience in parenteral and large molecule drug development and/or manufacturing.
  • Experience in dry product and small molecule drug development and/or manufacturing.
  • Experience in device development.
  • Biology, chemistry or engineering background and or experience.


Other Information:
Shift: Monday–Friday, flex time observed
Location: LTC-South, Indianapolis, IN
Travel Requirements: 5 - 20% approx.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-1431.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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