Clinical Data Analysis



  • Coordinate with statistician and project manager, assist in reviewing statistical analysis plan (SAP), study protocol, CRF, and analysis file specifications. 
  • Collect, maintain, analyze and interpret safety data that are collected either during pre-clinical studies conducted in bioresearch labs, or during clinical trials. 
  • Use solid SAS/STAT/MACRO/GRAPH/SQL techniques to analyze the data and generate Ad-hoc safety summary reports for review by research scientists and medical directors.
  • Perform statistical analysis using various statistical procedures including descriptive analysis (PROC FREQ and PROC UNIVARIATE) and inferential analysis (PROC MIX, PROC GLM, PROC LIFETEST and PROC PHREG).
  • Provide SAS programming support to Statisticians, data management team, medical writers, and clinicians to analyze clinical trial data.
  • Develop SAS programs, SAS macros to create tables, graphs and listings, and provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation.
  • Generate and validate SDTM and AdaM datasets for multiple phase II- III studies, integrate Summary of Safety and Efficacy (ISS/ISE) for FDA submission. 
  • Manipulate, analyze and report CDISC data by SAS/STAT including PROC LIFETEST, PHREG, MEANS, SORT, FREQ, SUMMARY, TANSPOSE, COMPARE, NPAR1WAY, ARRAY. 
  • In addition, the candidate will work closely with project manager, assist clients in their inquiries on clinical trial related statistical analysis with developing SAS tools and techniques.

Business Analytics


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Clinical Data Analytics