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Senior Statistical Programmer, CDISC SDTM/ADaM
DBV TechnologiesSenior Statistical Programmer supporting clinical studies with SDTM/ADaM compliance at DBV Technologies. Producing and validating deliverables, collaborating with biostatisticians and regulatory teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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 ProgrammingCDISC SDTM StandardsCDISC ADaM StandardsRegulatory SubmissionsPinnacle 21
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
SASStatistical AnalysisStatistical ProgrammingCDISC DeliverablesStatistical Analysis PlansSDTM/ADaM QATLFs (Tables, Listings, Figures)Regulatory RequirementsSAS StudioSAS Viya
Certifications & Qualifications
Master's Degree (MSc) or PhD in Biostatistics, Statistics, Mathematics
Industry Keywords
Clinical StudiesBiostatisticsRegulatory ComplianceStatistical Programming Standards
About the role
Key responsibilities & impact- 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
What you’ll need- 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)
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options