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Senior Statistician
 Spectraforce Technologies | |
 United States, New Jersey, Rahway | |
 Apr 08, 2025 | |
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Senior Statistician
7 months Rahway, NJ 07065 For hybrid schedule, work location is Rahway, NJ (3dys/week onsite) Qualifications: Education and Minimum Requirement: * PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or MS in Statistics/Applied Statistics with a minimum of 9 years relevant work experience. Skill sets required: * Knowledge of SAS and JMP necessary * Experience in analytical method qualification and validation including development of protocols, statistical analysis, and support of protocol deviations and laboratory investigations and generation of guidance for protocol criteria. * Design of Experiments Nice to haves/preferred:- * Mixed-effect modelling * Bayesian analysis * Skilled in writing statistical software code - in particular, software to support the statistical team (or other internal group) and that required qualification or validation. * Has demonstrated presentation skills - including presentation to improvement teams and management. Other * Experience in analysis of stability data, formulation designs and analysis. Responsibilities: Analytical Method Development * Design experiments to determine improvements to analytical methods or to assess their robustness. * Provide guidance for method criteria (e.g., system suitability). Analytical Method Qualification and Validation * Work with the laboratory to develop protocols. * Author memos and reports with statistical analysis. * Support laboratory in the assessment of deviations from protocol and in the investigation and resolution of any issues arising during validation. * Provide guidance for setting validation criteria. | |