Clinical Application Specialist

Job Summary

A company is looking for a Clinical Application Specialist II to lead statistical programming activities for clinical safety data sets.

Key Responsibilities

• Lead the creation and validation of SDTM, ADaM, and TLFs for clinical study reports
• Oversee compound level data integration efforts and ensure internal consistency of output
• Provide timely responses to client requests and implement process improvements

Required Qualifications

• BS or MS in Computer Science, Statistics, or a related field with SAS programming experience
• Extensive experience with clinical trials and regulatory agency expectations
• Strong skills in SDTM and ADaM datasets creation and validation
• Hands-on experience in SAS programming on LINUX and macro development
• Demonstrated ability to interpret statistical analysis plans for dataset specifications