This role will be supporting the Protocol writing of Phase 1 clinical pharmacology studies, pharmacokinetic and/or pharmacodynamic analysis using non-compartmental methods, and reporting for clinical trials Phase I – IV utilizing Phoenix WinNonlin and R on client systems.


Deliverables:
• Services rendered will adhere to applicable SOPs, Work Instructions, policies, local regulatory requirements, ICH-GCP guidelines, etc.
• For clinical pharmacology trial protocols, author the protocol and coordinate the overall development of the protocol with study team members, and ensure timely approval and issuance of the document.
• Provide QC review of protocols as needed.
• Review dataset requirements (i.e., trial specific data transfer agreement) for clinical studies with non-compartmental analysis (NCA).
• Write the Clinical Pharmacology Analysis Plan (CPAP) based on the protocol.
• Generate a logbook with data handling rules prior to the final NCA.
• Perform preliminary, interim, and final PK, PD, and/or PK/PD analysis for trials in all phases of drug development.
• Creation of tables, listing and figures based on the CPAP.
• Draft the clinical pharmacology sections of the Clinical Study Report.
• QC of analysis, all delivered outputs, and of documents reporting the analysis.

Education and Experience Requirements/Qualifications:

• Bachelor’s degree or higher and / or equivalent preferably with science background
• Excellent hands-on knowledge of PK & PD software packages
• Excellent data-handling skills and working knowledge of database structures
• Good knowledge noncompartmental PK analysis & PK/PD analyses
• Knowledge of Phoenix WinNonlin is a must.
• Demonstrated written and verbal communication.
• Working knowledge of Microsoft suite of software product and data analyses software packages
• Experience with R is preferred