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Cmc Statistician Jobs in Indiana (NOW HIRING)

Cmc Statistician information

Will AI replace statistician?

AI is a tool that can automate data analysis tasks, but CMC Statisticians play a critical role in designing studies, interpreting results, and ensuring data quality. While AI can assist with routine analyses, statisticians are essential for complex decision-making, model development, and contextual understanding. The profession is evolving to incorporate AI skills, but human expertise remains vital for accurate and ethical data interpretation.

What is a CMC statistician?

A CMC statistician specializes in biostatistics and data analysis related to Chemistry, Manufacturing, and Controls (CMC) processes in pharmaceutical development. They design studies, analyze data, and ensure compliance with regulatory standards to support drug approval. Proficiency in statistical software and understanding of regulatory guidelines are essential for this role.

What jobs make $1,000,000 a year?

In the field of CMC statistics, earning $1,000,000 annually is uncommon and typically limited to senior roles such as chief data officers or high-level consultants in large organizations. These positions often require extensive experience, advanced degrees, and specialized skills in data analysis, statistical modeling, and leadership. Most statisticians, including those in CMC, earn significantly less, with top executives and consultants reaching higher compensation levels.

Are statisticians still in demand?

Statisticians, including CMC statisticians, are in steady demand across industries such as healthcare, pharmaceuticals, and data analysis. Their skills in data interpretation, statistical software, and regulatory knowledge are highly valued, with employment growth expected to continue as data-driven decision making expands.

How does a CMC Statistician typically collaborate with cross-functional teams during pharmaceutical product development?

As a CMC Statistician, you will regularly work with scientists, analytical chemists, and process engineers to design experiments and analyze data related to drug formulation and manufacturing. Your role involves translating technical requirements into statistically sound studies, interpreting results for non-statistical team members, and ensuring compliance with regulatory standards. Effective communication and teamwork are vital, as your insights guide decision-making in process optimization, quality control, and regulatory submissions throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a CMC Statistician, and why are they important?

To thrive as a CMC Statistician, you need a strong background in statistics, pharmaceutical sciences, and regulatory requirements, often supported by an advanced degree in statistics or a related field. Expertise with statistical software such as SAS, R, and knowledge of data management systems and ICH guidelines is typically required. Strong analytical thinking, attention to detail, and effective communication skills help in interpreting complex data and collaborating with cross-functional teams. These competencies ensure robust data analysis, regulatory compliance, and reliable decision-making in drug development processes.
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Infographic showing various Cmc Statistician job openings in Indiana as of July 2026, with employment types broken down into 2% As Needed, 79% Full Time, 17% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution.

Principal Statistician - Manufacturing

Eli Lilly and Company

Indianapolis, IN

$112K - $193K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 29 days ago


Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 63 frontline employees who took The Breakroom Quiz

11th of 86 rated pharmaceutical


Job description

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

At Lilly, we serve an extraordinary purpose.We make a difference for peoplearound the globeby discovering,developingand delivering medicines that helpthemlive longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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

  • Master degree in Statistics.

  • At least 1 years of experience in industrial statistics.

Additional Skills/Preferences

  • CMC experience highly preferred

  • 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.

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 Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$112,500 - $193,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly


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About Eli Lilly

Sourced by ZipRecruiter

Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Indianapolis, IN, US

Year founded

1876