Statistician - IIILocation: 126 E. Lincoln Avenue, Rahway, NJ 07065 Rate: $65/HRQualifications: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.Must haves: • SAS and JMP • Clinical/Non clinical statistical experience. • DOE • Need someone familiar with statistical experience in the analytical development field.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 ExperimentsNice 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.Note: • Open to both hybrid and remote applicants. • For hybrid schedule- work location is Rahway, NJ(3dys/week onsite) • Candidate with only BS/BA will not be considered.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.