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 fields3+ 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 datasets3+ 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 spaceMastery of statistical methods such as Design of Experiments (DoE), Analysis of Variance (ANOVA), Mixed models, and Multivariate AnalysisPreferred Requirements :
Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics backgroundFamiliarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distributionKnowledge of Statistical process control, Variance component analysis, and Bayesian methodologyPay : $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 responsesCollaborate with Manufacturing, Manufacturing Science &Technology, and process analytics teams to design studies and analyze complex datasets, driving process robustness and improvementSupport teams in method lifecycle management and reference standard qualification, including development, validation, and investigationsDevelop and implement statistical approaches for study design and data analysis to ensure batch compliance and reduce risks of rejection or recallPerform thorough statistical analyses, provide data-driven insights, and recommend actionable solutions aligned with business needsContributes to improvement and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where requiredEnhance statistical awareness across the organization by supporting training and development in statistical methods and process control