- Support clinical studies through statistical programming compliant with CDISC standards (SDTM/ADaM)
- Produce, validate, and review CDISC deliverables
- Execute and support statistical analyses
- Collaborate with biostatisticians in study design
- Write and review Statistical Analysis Plans (SAPs)
- Validate regulatory submission deliverables
Requirements
- 6-8 years in SAS
- SDTM/ADaM QA
- Regulatory submissions (Pinnacle 21)
- Master's degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or a related field
- Proficiency in SAS (Base SAS, SAS Studio, SAS Viya)
- Strong expertise in CDISC SDTM and ADaM standards
- Knowledge of TLFs (Tables, Listings, and Figures) and regulatory requirements
- Experience using Pinnacle 21
- Fluent English (written and spoken)
Core Competencies
Demonstrates expertise in statistical programming and analysis, particularly in SAS, while ensuring compliance with CDISC standards for clinical studies. Proficient in producing and validating regulatory submission deliverables and collaborating effectively with biostatisticians.
Highest-signal resume keywords
- SAS Programming
- CDISC SDTM Standards
- CDISC ADaM Standards
- Regulatory Submissions
- Pinnacle 21
ATS Optimization Keywords
Hard Skills
- SAS
- Statistical Analysis
- Statistical Programming
- CDISC Deliverables
- Statistical Analysis Plans
- SDTM/ADaM QA
- TLFs (Tables, Listings, Figures)
- Regulatory Requirements
- SAS Studio
- SAS Viya
Certifications & Qualifications
- Master's Degree (MSc) or PhD in Biostatistics, Statistics, Mathematics
Industry Keywords
- Clinical Studies
- Biostatistics
- Regulatory Compliance
- Statistical Programming Standards