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Senior PK Data Analyst
Advion BioServices
Description:
The Senior PK Data Analyst provides data modeling, analysis, and interpretation and writes final reports for toxicokinetics (TK) and pharmacokinetics (PK) studies. This individual will use software such as Pharsight WinNonlin or similar software to model, interpret, and present PK and TK data. This individual will write SOPs and work with IT and QA to validate software in our environment to ensure compliance with GLP, GCP and 21 CFR Part 11 regulations.
PRINCIPAL RESPONSIBILITIES:
- Noncompartmental PK/TK analysis
- Compartmental PK/TK modeling
- Generate appropriate tables and graphics for inclusion in the final PK/TK report
- Write the final PK/TK report
- Work with IT and QA to validate software in our environment in compliance with GLP, GCP and CFR Part 11 regulations
- Write SOPs for PK/TK modeling, data analysis, and reporting functions.
- Conduct all work in compliance with GLP or GCP regulations.
Requirements:
Pharm D or doctorate degree in pharmaceutical sciences, toxicology, medicinal chemistry or a related field with progressively responsible and relevant experience in PK interpretation of two years or more. Educational achievements of a lower level must be accompanied by appropriate additional experience and proven record.
This position is located in Ithaca, NY. Relocation assistance is available.
EOE. |
