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
Other/Not Classified
Company Size
100 to 499 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
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.