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TSR Consulting

Statistician (New Brunswick)

TSR Consulting, New Brunswick, New Jersey, United States, 08933

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**Local candidates ONLY please to New Brunswick NJ **MUST have pharmaceutical experience

83507

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Statistician for a 12+ months contracting assignment.

Must have skills:

Required MS or PhD in Statistics, Biostatistics, Applied Mathematics, or other related fields 3+ years of experience in applying statistical methodologies such as Linear regression, Analysis of variance (ANOVA), Design of Experiments (DoE), Mixed models, and Multivariate Analysis to real datasets 3+ years of experience in one or more statistical software (e.g., JMP, SAS, R, or Python) 1+ years of data analysis experience in the Biopharma space Mastery of statistical methods such as Design of Experiments (DoE), Analysis of Variance (ANOVA), Mixed models, and Multivariate Analysis

Preferred Requirements: Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background 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

Pay: $59-60/hour W2

Location: New Brunswick NJ

Responsibilities: Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses Collaborate with Manufacturing, Manufacturing Science &Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvement Support 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 Perform thorough statistical analyses, provide data-driven insights, and recommend actionable solutions aligned with business needs Contributes to improvement and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where required Enhance statistical awareness across the organization by supporting training and development in statistical methods and process control