Sr. Statistical ProgrammerPVR Technologies, Inc
Sr. Statistical Programmer
BS degree in Statistics Biotechnology with 5 years of experience. Create, maintain, & modify SDTM & ADaM spec., following CDISC std., Validate SDTM & ADaM datasets including running validation macros and/or proc compares to check accuracy of datasets. Create, maintain, & modify TFLs utilizing TFL Spec., & macros. Prepare ISE & ISS reports. Wrk., w/ UNIX & in WINDOWS environments & on CDISC, ICH, GCP guidelines. Experience in FDA, ICH-GCP guidelines, 21 CFR Part 11 & CDISC SDTM/ADaM std., for regulatory submissions. Working with CDISC SDTM 3.1.2/3.1.3/3.2 versions std., & application creating domains including but not limited to interventions, findings & events. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.