Experience

CRC Pharma

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• SAS clinical programmer

  • May 2013 - Present

  Working as SAS consultant to map clinical trial data to CDISC SDTM standards and to generate SAS compliant datasets. Develop annotated SDTM CRFs and create mapping specifications from source CRF data to meet CDISC SDTM standards/sponsor standards. Develop and validate CDISC SDTM Datasets using SAS and SAS DI Studio tools. Work on modifying macros and also code macros from scratch. Create transport files and define documents for electronic submissions to FDA. Develop programs in SAS to produce outputs in accordance with specifications for both CDISC and NON CDISC studies. Analyze source raw data coming from EDC like RAVE, INFORM, and ORACLE CLINICAL and converted into CDISC SDTM datasets following CDISC standards. Convert different formats of data (Excel, Access, Plan text file) to SAS datasets. Perform data validation/QC of CDISC SDTM datasets and/or mapping specifications to meet FDA standards



Rcube analytics

• 525 North Tryon Street, Charlotte, NC

• SAS Clinical Programmer

  • Jun 2009 - Apr 2013

  Involved in different client studies. Involved in different Phases of Clinical Trials. Understanding SAP and working with Statistician to develop specs. Involved in creating CDISC--SDTM/ADAM datasets. Involved in generating Safety and Efficacy summary Tables, Listings and Graphs for FDA regulatory submissions. Knowledge of ICH-GCP guidelines, 21 CFR Part 11, and CDISC standards for regulatory submissions. Experience in design, development, documentation and validating the applications



Western Kentucky University

• United States
• Higher Education
• 700 & Above Employee

• SAS Research Analyst

  • Aug 2007 - Jun 2009

  Coordinated course evaluations in the fall and spring semesters Communicated with departments and colleges on courses/instructors to be evaluated Coordinated the compilation, printing, distribution, scanning, and transcription of evaluation forms Prepared and distributed evaluation results to departments and instructors Analyzed and presented data as a part of the department’s mission of executive decision support Imported and converted Text Based Data files into SAS Data Sets for analysis. Worked extensively with SAS Functions/Macros/Procedures. Developed SAS Macros to ease the process of coding, to standardize programs, for data.



S.R.R College of Pharmaceutical Sciences

• lecturer

  • Nov 2006 - Aug 2007

  Biostatics and Data Analysis, Clincail trial data management Biostatics and Data Analysis, Clincail trial data management