Winnonlin scientific software
What are the Preferred Skills required for this Job/Position? What is the Experience Required for this Job?ġ-3 years of hands-on experience in PK analysis, interpretation and reporting of clinical trials data using WinNonlin® / Phoenix WinNonlin® software. Master of Pharmacy (M.Pharmacy) in Pharmacology / Pharmaceutics / Pharmaceutical technology.
What are the Educational Qualification(s) for this position(s)?
#Winnonlin scientific software iso
Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs.Co-ordinates cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects.Perform quality control and quality assurance of PK deliverables as per the client assignment specifications.Prepares SAS® transport files for regulatory submission.Creates Tables, Listings, and Figures (TLFs), and summary reports for regulatory submission.Creates Non-compartmental analysis (NCA) workflows in Phoenix WinNonlin® 6.3 or higher.
Merges concentration-time data and performs data cleaning process.Prepares and understands Pharmacokinetic Analysis Plan (PKAP).Reads and understands the study protocol, PK analysis specifications worksheet, and project requirements.Vacancy for Associate Scientist at Cytel Inc.