Programming edit checks for Data Management with SAS; Create tables, listings and figures for clinical study report; Annotated blank CRF (acrf.pdf) following FDA/CDISC or sponsor guidelines; Create or QC SDTM specifications and SDTM datasets; Create or QC ADaM specifications and ADaM datasets; Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf); Create define.xml or define.pdf following FDA/CDISC or sponsor guidelines
Requirements:
Bachelor’s degree in computer science (CS), statistics or related scientific disciplines with 7 yrs. clinical programming experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming experience; Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology; Good understanding of clinical drug development process
Text:
Principal Statistical Programmer/Analyst Programming edit checks for Data Management with SAS; Create tables, listings and figures for clinical study report; Annotated blank CRF (acrf.pdf) following FDA/CDISC or sponsor guidelines; Create or QC SDTM specifications and SDTM datasets; Create or QC ADaM specifications and ADaM datasets; Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf); Create define.xml or define.pdf following FDA/CDISC or sponsor guidelines Bachelor’s degree in computer science (CS), statistics or related scientific disciplines with 7 yrs. clinical programming experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming experience; Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology; Good understanding of clinical drug development process
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