Statistician

• • 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