Job Description
Job Description:- 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.
Skills
Biostatisticsunmatched
Biotech and Pharmaceuticalunmatched
Case Report Form (CRF)unmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Trialunmatched
Code Reviewsunmatched
Contract Research Organization (CRO)unmatched
Data Processingunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
ICH Regulationsunmatched
Maintain Complianceunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Statistical Analysis System (SAS)unmatched
Traceabilityunmatched
Training Data Setsunmatched
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