Authoring the protocol and coordinating the overall development of the protocol with study team members, ensuring timely approval and issuance of the document.
Providing QC review of protocols as needed.
Reviewing dataset requirements (i.e. trial specific data transfer agreement) for clinical studies with non-compartmental analysis (NCA).
Writing the Clinical Pharmacology Analysis Plan (CPAP) based on the protocol.
Generating a logbook with data handling rules prior to the final NCA.
Performing premliminary, interim, and final PK, PD and/or PK/PD analysis for trials in all phases of drug development.
Creating of tables, listings and figures, based on the CPAP.
Drafting the clinical pharmacology sections of the Clinical Study Report.
QC of analysis, all delivered outputs, and of documents reporting the analysis.
Minimum degree: BA/BS in a health, science, or computer science related field.
3 years' industry experience.
Working knowledge of Phoenix WinNonlin is essential.
Working knowledge of Microsoft suite of software.
Knowledge of noncomparmental PK analysis and statistical principles.
Demonstrated written and verbal communication.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development., Why ICON?