Skills Required JOB DESCRIPTION Basic knowledge in Phoenix WinNonlin® software in creating workflows independently. Demonstrated strong understanding of Drug Discovery and Development, PK/PD principles, physiology/pharmacology and biopharmaceutics through scientific presentations, posters and publications. Thorough knowledge regarding International Conference on Harmonization-Good Clinical Practice. Basic knowledge in using SAS® and R Programming. Basic knowledge in Medical and Scientific writing. Basic Knowledge regarding Clinical Trials Methodologies. Responsibilities Reads and understands the study protocol, PK analysis specifications worksheet, and project requirements. Prepares and understands Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications. Merges concentration-time data and performs data cleaning process. Creates/Reviews Non-compartmental analysis (NCA) workflows in Phoenix WinNonlin® 8.1 or higher. Creates Tables, Listings, and Figures (TLF), and summary reports for regulatory submission. Plays an active role in planning, execution, and delivery of pharmacokinetic assignments ensuring on-time quality deliveries. Prepares and reviews SAS® transport files for regulatory submission. Perform quality control and quality assurance of PK deliverables as per the client assignment specifications. Coordinates cross-functional activities involving statisticians, SAS® programmers, and medical writers involved in pharmacokinetic projects. Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799, and client’s SOPs. Reviews source, outcome database entries (i.e., ensures accurate publication digitization). Qualifications Master of Pharmacy (M. Pharmacy) in Pharmacology/Pharmaceutics/Pharmaceutical technology. 1-2 years of hands-on experience in PK analysis, interpretation and reporting of clinical trials data using Phoenix WinNonlin® software. Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts. Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications. Hands-on experience on Population PK (POP PK) using NONMEM® or Phoenix NLME, Statistical analysis using SAS® and Medical Writing activities would be an added advantage. Should have good academic credits and excellent communication skills (oral and written) About Us Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture. Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit! Show more Show less
