Associate Scientist QPP – at Cytel, Apply Now!
Looking to grow your career in pharmacokinetics and clinical data analysis? Cytel is hiring an Associate Scientist, QPP to join its expert team in advancing clinical development. This role is ideal for candidates with a strong foundation in PK/PD principles, experience using Phoenix WinNonlin®, and a passion for drug discovery and regulatory science. Join a global leader driving innovation in life sciences!
About Cytel:
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.
- 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 as Associate Scientist.
- 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 preferred for Associate Scientist.
- 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 for Associate Scientist:
- 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).
