Senior Clinical SAS Programmer Analyst
Senior Clinical SAS Programmer Analyst
MS degree in Biotech or Computer Science, with 2 years of experience; Work on ICH, GCP guidelines, CDISC principles and Phase I-IV Clinical studies. Generate SAS reports according to 21 CFR-Part11. Create datasets in CDISC SDTM V 3.1.2 format. Analyze data sets (ADAM) to reflect specification, ADAM implement, guide ans SAP. Use SAS/Macros in analysis of standards, clinical data, generate and evaluate Reports, Graphs, Listings, and Tables as per SAP, CRT's, Reporting and Analysis datasets. Use OPEN CDISC validator to validate SDTM and ADAM datasets. Create datasets like TR/RS/TU and write specifications, for database in CDISC format (STDM model 3.1) and NDA's (ISS/ISE). Produce safety and efficacy reports- ISS and ISE for submission to Regulatory Affairs. Work on ANOVA, Regression and correlation analysis. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.
Equal Opportunity Employer / Affirmative Action Minority/Female/Disability/Veterans