Careers

·        Provide validation services to client pertaining to drug development life cycle and manipulation, analysis and reporting of clinical trials data and Participate in the clinical trials process by reviewing CRFs, edit check specifications, mock tables/listings/figures.

o   Review the reports consisting of Tables, Listings and Graphs that are generated from the available databases.

o   Ensure Laboratory normal ranges are received and units are appropriate for the laboratory tests done as per standard operating procedures (SOPs).

·        Generate tables, listings and figures for inclusion in Clinical Study Reports, annual safety reports, and other documents, as requested.

o   Review and validate reports (Tables, Figures, Listings and Datasets) generated by others to support the reporting and analysis of clinical trial data.

o   Support reporting processes for collected clinical trial data for submission (NDA/BLA/IND, etc.) to Regulatory Authorities (FDA, EMEA, etc.) as per FDA regulations and ICH guidelines.

·        Identify data issues and report findings to the appropriate team members.

              o   Confirm appropriate Laboratory analytical method is used to perform the test.

              o   Understand the Laboratory data (Chemistry, Hematology, Microbiology and Urinalysis) and Pharmacology data to identify data issues, to ensure further data analysis and reporting by other line functions.

              o   Conduct analysis of the Pharmaceutical, Biochemistry and Laboratory data by various analytical methods using the provided software (e.g. Statistical Analysis System/SAS software).        

              o   Analyze the data and communicate with the Data Management / Analytical Laboratory personnel for resolving any outlier data, data issues and data discrepancies found.

·        Create SDTM and ADaM datasets based on CDSIC standards.        

              o   Review and maintain Datasets as per the CDISC (SDTM and ADaM) standards.

·        Participate in TLFs validation.

Qualification:

This position requires a minimum of a Bachelor’s degree in Statistics or a related science field (i.e. Pharmacy/Pharmaceutical Sciences), or a combination of education and experience equating to the U.S. equivalent in aforementioned subjects.