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Senior Scientist - QPP

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Date: Feb 19, 2021

Location: IN IN

Company: Cytel Inc

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

 

Summary of Job Responsibilities:     

    • Reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications.
    • Reads and understands the study protocol, PK analysis specifications worksheet, and project requirements.
    • Merges concentration-time data, applies data cleaning process, performs Pharsight® Knowledge Server data management and integration with Phoenix WinNonlin® software.
    • Creates and Reviews Non-compartmental analysis (NCA) workflows in Phoenix WinNonlin® 6.3 or higher.
    • Performs PK/PD analysis of preclinical and clinical data using Phoenix WinNonlin® 6.3 or higher software as per the 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.
    • Interprets PK results and prepares pharmacokinetic content for Clinical Study Reports (CSRs).
    • Prepares and reviews 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.
    • Co-ordinates with the client and US-team for clarity of specifications, data issues, reviews, schedules, etc.
    • 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 and Experience:

  • Minimum Education:
    • Master of Pharmacy (M. Pharmacy) in Pharmacology/Pharmaceutics/Pharmaceutical technology.

 

  • Minimum Work Requirements:
    • 5-8 years of hands-on experience in PK/PD 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.
    • 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).

 

  • Skills:
    • Expertise in WinNonlin® / 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.
    • Proficient in using SAS® and R Programming.
    • Proficiency in Medical and Scientific writing.
    • Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice.
    • Basic Knowledge regarding Clinical Trials Methodologies.


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