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.