Clinical SAS Developer
UpperGwynedd, PA /Rahway, NJ
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
Numbers & Facts
Location
Rahway, NJ
Industry
Medical Devices and Supplies
Company Size
500 to 999 employees
Skills
Biostatisticsunmatched
Biotech and Pharmaceuticalunmatched
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
Traceabilityunmatched
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