Anusha P

Senior Statistical Programmer @Veristat

GB

Experience in mapping of raw/legacy data to SDTM by following SDTM annotations/mapping specifications, CDISC standards and implementation guide.Creation of Migrated datasets from the raw data using Macros and the CRF. Worked with clinical data managers for writing edit checks and data listings for data cleaning and validation. Review study documents Protocol, CRF/database design, Data Management Plan and Statistical Analysis Plan and provided feedback. Worked with clinical data managers for writing edit checks and data listings for data cleaning and validation. Review study documents Protocol, CRF/database design, Data Management Plan and Statistical Analysis Plan and provided feedback. Extensively worked on generation of various efficacy Analysis datasets including ADTTE, ADPFS, ADTR, ADRS which involves generation of Censor variable, Overall response variable using RECIST criteria. Developed generalized utility macros to automate programs for standard reports and validations. Generated and reviewed customized reports and created Case Report Tabulations for NDA submission to the FDA (Food and Drug Administration). Actively participate in regular department meetings to discuss the work progress, raise any issues and provide input to timelines. Work on multiple studies and complete the assigned tasks within the timelines and with high quality.