Job Description

**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

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