Statistician

Statistician - CMC & Biopharmaceutical Manufacturing

New Brunswick, NJ

Base pay range: $65.00/hr - $66.00/hr

Contract Duration: 12-month contract (with possible extension)

Work Arrangement: 50% onsite required

Schedule: Monday to Friday, standard business hours

Join a leading global biopharmaceutical organization dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.

The Statistician will support various functions including development, process improvement, tech transfer, validation, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses. Support and guidance in relation to study design and data analysis are provided globally across company operations.

• Collaborate with stakeholders to identify statistical needs and apply appropriate methodologies.
• Partner with Manufacturing, Manufacturing Science & Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvement.
• Support Quality Control and Analytical Sciences & Technology teams in method lifecycle management and reference standard qualification, including development, validation, and investigations.
• Develop and implement statistical approaches for study design and data analysis to ensure batch compliance and reduce risks of rejection or recall. This may include specification setting, process capability, sampling plans, and product shelf life (expiry/retest periods).
• Perform thorough statistical analyses, provide data‑driven insights, and recommend actionable solutions aligned with business needs.
• Represent the statistics function at product development, product protocol, and management meetings.
• Contribute to the improvement and standardization of processes, procedures, and systems related to statistics while maintaining flexibility where required.
• Promote statistical awareness and process control competency across the organization through training and development.
• Foster a shared commitment to quality and compliance at every level.
• Demonstrate professionalism, collaboration, and a commitment to quality in daily responsibilities.

• MS in Statistics, Biostatistics, Applied Mathematics, or related field with 2+ years of experience, or PhD with no additional experience.
• 3+ years of experience applying statistical methodologies such as linear regression, ANOVA, Design of Experiments (DoE), mixed models, and multivariate analysis.
• 3+ years of experience using statistical software (e.g., JMP, SAS, R, or Python).
• 1+ year of data analysis experience in the biopharmaceutical industry.
• Strong communication skills and the ability to explain statistical techniques to non‑statisticians.
• Ability to manage multiple projects in a dynamic environment.

• Experience in biopharmaceutical development and manufacturing, especially with CMC statistics.
• Familiarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distribution.
• Knowledge of statistical process control, variance component analysis, and Bayesian methodology.

Associate

Contract

Science and Research

Pharmaceutical Manufacturing and Biotechnology Research

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