**Local candidates ONLY please to New Brunswick NJ
**MUST have pharmaceutical experience
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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
Job Type: Contract
Pay: $59.00 - $60.00 per hour
Work Location: In person
