Experienced with CDISC SDTM (IG 3.1.2 and 3.1.3) and ADaM (IG 1.0) standards. * Created safety, and efficacy SDTM and ADaM datasets, summary tables, listings and graphs (TLFs). * Proficient at using SAS data step and procedures. * Experienced in generating Integrated Summaries of Safety and Efficacy (ISS, ISE). * Validated Analysis datasets and TLFs using parallel programming and other validation techniques. * Created new macros and modified existing macros based on the departmental and study level requirements. * Experienced in writing SDTM mapping and ADaM specifications. * Experience in various therapeutic areas including oncology. * Performed incidence rate, survival and statistical analysis using proc lifetest and proc phreg. * Supported NDA submissions by reviewing define.xml, creating xpt files. * Programmed Edit Check programs to create reports for data cleaning and data validation. * Interacted with other departments such as Bio-Statistics, Data Management, Medical Writers etc. * Experienced in reviewing Protocol, SAP, Dataset specification and mock shells. * Excellent communication skills.

Highlights:

• Active Directory Application Mode (ADAM)
• Base SAS
• C Programming Language
• C++ Programming Language
• Catalogs
• Communication Skills
• Compliance
• Data Analysis
• Data Management
• Database