Job Description
Job DescriptionJob Title: Senior Statistician - III
Location: Rahway, NJ (Hybrid/ Remote)
Duration: 07 Months+
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 have/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 (3days/week onsite).
- Candidate with only BS/BA will not be considered.
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