Biostatistics background, good knowledge in SAS programming. Completely involved in SDTM,ADaM,CSDRG,ADRG,Annotation CRF works for CDISC submission and PK Studies for the FDA Submission. Providing input for sample size calculation, TLF shells, performing statistical analysis, writing statistical report, preparing randomization schedules and SAS programming. Specialties: SAS Programming (UNIX & WINDOWS), BA/BE Studies and PK Studies