Cytels award-winning statistical and predictive software solutions enable our clients to make the best possible decisions. Our software portfolio offers adaptive, Bayesian, and exact tools which allow you to go fast and learn as you go.
Post : Associate Scientist
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, and 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.
• 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.
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
Experience : 1-3 years
Qualification : M.Pharm
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th August, 2021
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