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Over a decade of experience in the Pharmaceutical and Clinical Research industry, I specialize in clinical research data analysis, statistical programming, CDISC Standards (CDASHIG, SDTMIG, ADAMIG, Pinnacle21), ICH-GCP Guidelines (E3, E6, E9), TFLs and regulatory submissions (aCRF, Programming Specifications/algorithms, SDTM, ADAM, SDRG, ADRG, ARM, SAS Pointers, Define). I have expertise in Cancer Research/Oncology studies Phase I/II/III (RECIST v1.1 Guidelines) and skilled in SAS, R, Python and SQL.