SAS Certified Programmer with experience in SAS Programming for various therapeutic areas in Clinical / Pharmaceutical Industry.• Overall 9+ Years of strong hands-on SAS experience with strong emphasis in clinical and statistical programming working in the pharmaceutical industry.• Good knowledge in understanding study related documents like CRF, Protocol, Statistical Analysis Plan and Mock shells.• Strong working knowledge with analysis of clinical trial data, generating reports as per company standards in compliance with CDISC and FDA Guidelines for Phase (I- III) Clinical Trial studies.• Good experience of CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).• Experience in annotating CRF according to CDISC SDTM standards.• Experience in creating Macros, using standard Macros, and modifying existing Macros to improve ease, speed, and consistency of results.• Good Experience in writing specifications and review for SDTM data mapping and ADaM derivations per the CDISC SDTM and ADaM standards.• Expert in SDTM data mapping and QC as per the CDISC standards including trial domains.• Expert in ADaM derivations and QC as per the SAP and TLF SHELLs.• Experience with the creation of ADSL, ADAE, ADLB, ADEG, ADVS, ADPC, ADPP and ADTTE datasets.• Experience in producing Reports, Listings, Tables, and Graphs (TLGs) based on the mock shells, and QC using double programming.• Good experience in data validation in P-21, addressing the issues, and adding justifications.• Experience in creating outputs in various formatted files such as XLSX, RTF, PDF, and HTML using SAS/ODS.• Experience in working different SAS environments like SAS Enterprise Guide and SAS Studio• Extensive experience in BASE SAS, SAS MACROS, SAS PROCS, SAS ODS.• Experience in developing Define.xml files for FDA submissions.• Participated in team meetings to discuss best programming practices. Established and maintained sound working relationship and effective communications within Biostatistics, Statistical Reporting, and the Data Management group.• Strong skills in SAS data step programming, including merging and reading external data files.• Extensively involved in Data Analysis and preparation of ADaM Datasets, Listings, tables and plots according to the Statistical Analysis Plan (SAP).
