Statistician III

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.

Education and Experience:

• 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.
• • Experience in analysis of stability data, formulation designs and analysis.

Must Have Skills:

• 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 Have Skills:

• 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.

Note:

• Open to both hybrid and remote applicants.
• For hybrid schedule- work location is Rahway, NJ(3dys/week onsite).