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How much do cmc statistics jobs pay per hour?

As of Aug 20, 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 is a CMC statistician?

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 the key skills and qualifications needed to thrive as a CMC statistician?

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 are some typical challenges faced by CMC statisticians, 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.

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 is a Cmc Statistics?

A Cmc Statistics role involves analyzing and interpreting data related to chemical, manufacturing, or clinical processes, often requiring knowledge of statistical methods and data analysis tools. Professionals in this field support quality control, process optimization, and regulatory compliance by providing accurate statistical insights.
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Cmc Statistics jobs near you
Infographic showing various Cmc Statistics job openings in the United States as of August 2026, with employment types broken down into 95% Full Time, and 5% Temporary. Highlights an 90% In-person, and 10% Remote job distribution, with an average salary of $80,700 per year, or $38.8 per hour.

Associate Director, Analytical Development and Quality Control

Kailera Therapeutics, Inc.

Remote

$155K - $190K/yr

Full-time

Medical, Life, Retirement

Re-posted 2 days ago

Job description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You'll Do:
The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera's pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company's integrated development plans and program timelines.
Responsibilities:
  • Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances..
  • Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance.
  • Through our external network, lead the development of analytical methods that support Kailera's product pipeline, including analytical transfers and troubleshooting in CDMO laboratories.
  • Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
  • Author relevant CMC sections to enable global regulatory filings.
  • Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed.
  • Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making.
  • Collaborate with cross-functional line functions to ensure CMC and program goals are met.
  • Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.

Required Qualifications:
  • A bachelor's degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.).
    • Or an advanced degree with 5+ years
  • Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation.
  • Demonstrated analytical project leadership and cross-functional team participation.
  • Experience in setting commercial specifications.
  • Experience in authoring regulatory documents, including NDA experience
  • Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements.
  • Strong understanding of all applicable ICH guidelines.
  • Method validation experience.
  • Experience with oversight of the analytical activities at CDMOs and/or CTLs.
  • Sound problem-solving skills with technically driven decision-making ability.
  • Effective written and verbal communication and interpersonal skills.
  • Innovative team-player with high energy for our dynamic company environment.

Preferred Qualifications:
  • Knowledge and experience in analytical development of injectable products, and associated control strategies
  • Knowledge and experience in analytical development of small molecules and solid oral dosage forms.
  • Successful support of at least one NDA and commercial launch.
  • Synthetic peptide manufacturing knowledge.
  • Experience with statistics and applying statistics to analytical chemistry.
  • Regulatory Inspection experience.

Education:
  • A Bachelor's degree with 10+ years or an advanced degree with 5+ years of relevant experience
  • Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.

Additional Information:
  • This position requires some travel to domestic and international destinations.
  • In rare occasions, this position may require working in environments where there may be specific gowning or dress code requirements.

Salary Range
$155,000-$190,000 USD
For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify:
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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