Title : Biostatistician
Duration : 6+ months
Location: Rahway, NJ (Hybrid 3 days onsite)
Rate : $ 65.80/hrs on w2
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.
Job Description:
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.
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.
• Experience in analysis of stability data, formulation designs and analysis.