Clinical Application Specialist III

A company is looking for a Clinical Application Specialist III.

Key Responsibilities

Lead statistical programming activities for development and maintenance of integrated clinical safety data sets

Oversee the creation and validation of SDTM, ADaM, and TLFs for regulatory submissions

Ensure compliance with internal processes and provide timely responses to client requests

Required Qualifications

BS or MS in Statistics, Computer Science, or a related field with at least 8 years of SAS programming experience

Extensive experience with clinical trials and familiarity with regulatory agency expectations

Proficient in SDTM and ADaM datasets creation and validation

Strong technical competence in SAS programming, including macro and utilities development

Experience in leading data integration efforts and supporting safety reporting deliverables