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Cmc Statistics Jobs (NOW HIRING)

Moderna, Inc.

Sr. Manager, CMC Stability

Norwood, MA · On-site

Review and interpret stability data, perform trending analyses, and support statistical evaluations ... Experience working in cross-functional CMC teams within a matrixed development or commercial ...

Northeastern University

Regulatory Fellow

Boston, MA · On-site

$76K - $107K/yr

... and Controls (CMC) and gain specialized experience in the development of regional or global ... design, statistics, and clinical pharmacology. • Ability to assess and understand complex ...

Vrtx

AS&T Principal Scientist - CGT & Biologics

Boston, MA · Hybrid

$138K - $207K/yr

... CMC implementation. * Perform data verification, trending and statistical analysis to support regulatory strategy and product characterization. * Collaborate cross-functionally with internal ...

NorthEastern

Regulatory Fellow

Boston, MA · Hybrid

$76K - $107K/yr

... and Controls (CMC) and gain specialized experience in the development of regional or global ... statistics, and clinical pharmacology. Ability to assess and understand complex scientific ...

Commercial Metals Company

Reliability Engineer

Birmingham, AL · On-site

$96K - $120K/yr

At CMC, it's the people inside our recycling centers, fabrication plants, steel mills and offices ... Apply data analysis techniques (including statistical process control, reliability modeling and ...

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How much do cmc statistics jobs pay per hour?

As of Jun 5, 2026, the average hourly pay for cmc statistics in the United States is $38.80, according to ZipRecruiter salary data. Most workers in this role earn between $19.71 and $58.41 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) Statistician, and why are they important?

To thrive as a CMC Statistician, you need a strong background in statistics, pharmaceutical sciences, and regulatory guidelines, typically supported by an advanced degree in statistics or a related field. Proficiency with statistical software such as SAS, R, and familiarity with quality systems and ICH/FDA guidelines is essential. Attention to detail, problem-solving skills, and strong communication abilities help you effectively analyze complex data and collaborate with cross-functional teams. These skills are crucial for ensuring product quality, regulatory compliance, and the successful development and manufacturing of pharmaceuticals.

What is the difference between Cmc Statistics vs Data Analyst?

AspectCmc StatisticsData Analyst
Required CredentialsBachelor's in Statistics, Mathematics, or related field; often certifications in statistical softwareBachelor's in Data Science, Statistics, or related; sometimes certifications in data tools
Work EnvironmentResearch labs, pharmaceutical companies, or biotech firmsBusiness, finance, healthcare, or tech companies
Industry UsagePrimarily in pharmaceutical and biotech industries for clinical data analysisAcross various industries for interpreting data and supporting decision-making

While both roles involve data analysis, Cmc Statistics focuses on clinical and pharmaceutical data within biotech industries, requiring specialized knowledge of regulatory standards. Data Analysts work across diverse sectors, analyzing data to inform business strategies. Understanding these differences helps in choosing the right career path or job search focus.

What are CMC Statistics professionals and what do they do?

CMC Statistics professionals specialize in the application of statistical methods to Chemistry, Manufacturing, and Controls (CMC) activities within the pharmaceutical and biotechnology industries. Their work involves designing experiments, analyzing data, and ensuring product quality throughout the drug development and manufacturing process. They collaborate with scientists, engineers, and regulatory teams to support submissions to health authorities and maintain compliance with industry standards. By providing statistical expertise, CMC statisticians help optimize processes, validate analytical methods, and ensure consistency and safety of pharmaceutical products.

What are some typical challenges faced by professionals in CMC Statistics, and how can they be addressed?

Professionals in CMC Statistics often encounter challenges such as managing large and complex datasets, ensuring data integrity across multiple stages of drug development, and effectively communicating statistical findings to multidisciplinary teams. Staying current with regulatory requirements and adapting to evolving analytical methods are also key challenges. These can be addressed by using robust data management systems, fostering strong cross-functional collaboration, and participating in ongoing professional development to stay updated with industry trends and regulatory guidance.
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Cmc Statistics jobs near you
Principal Statistician - Manufacturing

Principal Statistician - Manufacturing

Eli Lilly and Company

Indianapolis, IN • On-site

$112K - $193K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 8 days ago

Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 62 frontline employees who took The Breakroom Quiz

11th of 71 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 people around the globe by discovering, developing and delivering medicines that help them live 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 3 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.
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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

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