Clinical Application Specialist

A company is looking for a Clinical Application Specialist to oversee statistical programming activities and ensure the accuracy of clinical data sets.

Key Responsibilities

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

Oversee the creation and validation of SDTM, ADaM, and TLFs according to project standards

Ensure internal consistency of outputs and implement process improvements

Required Qualifications

BS or MS in Statistics, Computer Science, or 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

Hands-on experience in SAS programming, including macro and utilities development

In-depth knowledge of CDISC data standards and experience in leading data integration efforts