Clinical Application Specialist

A company is looking for a Clinical Application Specialist II to lead statistical programming activities for clinical safety datasets. Key Responsibilities Lead data integration to create pooled ADaM datasets from multiple studies Oversee the creation and validation of SDTM, ADaM, and TLFs for regulatory submissions Develop and validate ADaM specifications and SAS programs for submissions Qualifications BS / MS in Computer Science, Statistics, or related field SAS programming experience in the pharmaceutical or biotech industry Strong background with clinical trials and regulatory agency requirements (FDA / EMEA) Hands-on expertise with SDTM / ADaM dataset creation and validation Proficiency in SAS programming on Linux and Linux shell scripting