Clinical Application Specialist

Job Summary

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