Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and pharmaceutical development markets.
Post : Associate Scientist - QPP
Job Description
• Reads and understands the study protocol, PK analysis specifications worksheet, and project requirements.
• Prepares and understands Pharmacokinetic Analysis Plan (PKAP).
• Merges concentration-time data and performs data cleaning process.
• Creates Non-compartmental analysis (NCA) workflows in Phoenix WinNonlin® 6.3 or higher.
• Creates Tables, Listings, Figures (TLFs), and summary reports for regulatory submission.
• Prepares 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.
Candidate Profile
• Master of Pharmacy (M.Pharmacy) in Pharmacology / Pharmaceutics / Pharmaceutical technology.
• 1-3 years of hands-on experience in PK analysis, interpretation, and reporting of clinical trials data using WinNonlin® / 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).
• Expertise in WinNonlin® / Phoenix WinNonlin® software in creating workflows independently.
• Demonstrated strong understanding of Drug Discovery and Development, and biopharmaceutics through scientific presentations, posters and publications.
• Proficiency in Medical and Scientific writing.
• Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice
Additional Information
Qualification : M.Pharm
Experience : 1-3 years
Location : Kanpur
Industry Type : Pharma
End Date : 28th February, 2022
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