BioStatistician

Title: Statistician - III (Senior)     

Location: Rahway, NJ 07065 (Hybrid with 3 days onsite; Remote considerable)

Duration: 07 Months

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) 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 the 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.