Scientist, Qpp

Job Description (JD) for Scientist, QPP Role: Summary of Job Responsibilities: Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements. Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications. Performs Integral data management, data cleaning process, and integration with Phoenix WinNonlin® software. PK/PD analysis using Phoenix WinNonlin® 8.1 or higher software, in accordance with study specifications. Plays an active role in planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality deliveries. Creates Tables, Listings, and Figures (TLFs), and summary reports for regulatory submission. Perform quality control and quality assurance of PK deliverables as per the client assignment specifications. Should be proactive to pursue advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives. Co-ordinates with the Client POCs for clarity of specifications, data issues, reviews, schedules, etc. Co-ordinates 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. Qualifications and Experience: Minimum Education: Master of Pharmacy (M. Pharmacy) / in Pharmacology/Pharmaceutics/Pharmaceutical technology Minimum Work Requirements: 4-6 years of hands-on experience in PK/PD 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. Should have good academic credits and excellent communication skills (oral and written). Skills: Expertise 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. Proficiency in Medical and Scientific writing. Proficient in using GraphPad Prism, R Programming and SAS® software. Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice. Basic Knowledge regarding Clinical Trials Methodologies

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