Skills
• Clinical Programmer with 6 years of SAS expertise, including 2 years of experience working with both SAS and R on CDISC standards, with an ability to create SDTM/ADaM datasets, Tables, Listings and Figures (TLFs) within Contract Research Organizations (CROs) and pharmaceutical organizations.
• Proficient in R tidyverse group of packages for creating SDTM/ADaM datasets.
• Hands on working experienced in Phase I-III of clinical trials and various therapeutic areas including Oncology.
• Proficient in validating SDTM/ADaM datasets, Tables, Listings and Figures (TLFs) adhering to CDISC guidelines.
• Experience in writing SDTM and ADaM Mapping specifications according to the CDISC standards and Proficiency in using SAS/ODS to create RTF, PDF and HTML format files.
• Involved in FDA submissions by creating aCRF, xpt files, define.xml and reviewer’s guide.
• Knowledge in MedDRA and WHO-DRUG dictionaries for coding and classifying medical terms and drug information.
• Ability to work in a cross-platform environment that includes Windows and UNIX Operating Systems.
About
With over six years of experience as a Clinical SAS Programmer in pharmaceutical and CRO environments, I have developed strong expertise in SAS, SQL, and R programming, data analysis, report development, and database management. My experience creating accurate reports, analyzing complex data, and supporting cross-functional teams aligns well with any organization's needs.