Bilingual Registered Dietitian Clinical Research - PRN Professional Case Management
Long Island, NY4 days ago
- $50
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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
Description
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
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 |
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