Biostatistics, Biotech and Pharmaceutical, Clinical Data Interchange Standards Consortium (CDISC), Clinical Trial, Code Reviews, Contract Research Organization (CRO), Data Processing, Documentation, FDA (Food and Drug Administration), ICH Regulations, Maintain Compliance, Regulatory Compliance, Traceability
Primary & Secondary Skill: SDTM/Clinical SAS
1.Must have 6-8 yrs of exp in clinical domain
2.Strong knowledge of SDTM
3.Create advanced SAS macros, templates, and utilities for efficient data processing
4.Act as the primary programming point of contact for biostatisticians and study teams
5.Perform peer review of code and documentation for accuracy and traceability
6.Review CRF (Case Report Form) annotations and data specifications.
7.Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines
Skill:
1.Extensive programming experience in a clinical trial environment (CRO/Pharma).
2.Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
3.In-depth knowledge of CDISC standards and regulatory submission requirements