Clinical Application Specialist III

Join to apply for the Clinical Application Specialist III role at Katalyst CRO
.

• In-depth knowledge of CDISC Standards, SAS programming concepts, and techniques appropriate to the pharmaceutical industry.
• Experience leading compound-level data integration efforts to create pooled ADAM datasets from multiple studies across indications.
• Experience in ADaM specification and SAS programs development supporting ISS/Client ADaM programming and submissions.
• Oversee and be responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following Client's SOPs, department, and project standards.
• Support IB, DSUR, and Annual Safety Reporting deliverables.
• Ability to quickly learn internal macros, processes, and programming environment.
• Team player with excellent communication skills, engaging with statisticians, data management personnel, and Pharmacovigilance stakeholders.
• Ensure accurate derivations as defined in the protocol and statistical analysis plan.
• Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data).
• Interpret statistical analysis plans to develop analysis data set specifications.
• Implement all Client's process improvements.
• Provide accurate and timely responses to client requests with urgency.
• Maintain compliance with training requirements.

• BS or MS in Statistics, Computer Science, or related field with at least 8 years of SAS programming experience in the pharmaceutical or related industry.
• Extensive experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Excellent working experience in SDTM and ADaM datasets creation and validation.
• High degree of technical competence and excellent oral and written communication skills.
• Hands‑on experience in SAS programming, macro, and utilities development.

Des Plaines, IL $92,412 - $115,032