Associate Scientist, QPP

Skills Required:

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.

Basic knowledge in using SAS and R Programming.

Basic knowledge in Medical and Scientific writing.

Basic Knowledge regarding Clinical Trials Methodologies.

ShortDescriptionStr

Associate Scientist with 1- 2 years of experience to perform Pharmacokinetic Analysis using WinNonlin Software

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)

InternalQualificationsStr

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)

InternalResponsibilitiesStr

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.

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).

ExternalResponsibilitiesStr

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.

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).