SDTM, Clinical SAS Programmer

• Looking for SDTM experts having in-depth knowledge of SAS programming(macro's).
• Must have 10 yrs of exp in clinical domain.
• Strong knowledge of SDTM.
• Create advanced SAS macros, templates, and utilities for efficient data processing.
• Act as the primary programming point of contact for biostatisticians and study teams.
• Perform peer review of code and documentation for accuracy and traceability.
• Review CRF (Case Report Form) annotations and data specifications.
• Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines.

Skill:

• Extensive programming experience in a clinical trial environment (CRO/Pharma).
• Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
• In-depth knowledge of CDISC standards and regulatory submission requirements.