Senior EDC Programmer - Data Quality & Automation Leader

CSL Vifor; King of Prussia (PA); Hybrid; USD 143,000 - 169,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

CSL Behring is seeking a Senior EDC Programmer to govern and validate data deliverables, lead EDC setup, and oversee data management systems across in-house, hybrid, and vendor studies. You will partner with Statistics, Data Management, and Standards to assure quality, SDTM/define.xml compliance, and scalable data platforms.

The role supports data automation initiatives, eCRF design, and data integration from external sources, contributing to efficient, regulatory-compliant data processing.

Qualifications

• Bachelor-level education in CS/Math/Stats or related field with relevant experience
• Medidata Rave Study Builder Certification is preferred
• 5+ years of clinical database design in EDC systems in pharma/CRO environments
• Experience with CDISC standards CDASH/SDTM and data submission readiness
• Proficient with EDC systems and data integration concepts

Responsibilities

• Drive design, development, and maintenance of clinical study databases with advanced technical expertise
• Collaborate with study teams to define data quality methods, criteria, and validation rules
• Oversee data quality control frameworks and validation libraries for vendor and internal data
• Govern a library of standardized reports to support study teams
• Oversee setup and monitoring of recurring data quality and operational reports
• Partner with Data Management, Statistics, and vendors for submission readiness
• Lead reporting solutions providing insights into data quality and study progress
• Ensure scalable data structures and integration for current and legacy data
• Support integration of external data sources and AI-enabled capabilities

Skills

CDISC standards

eCRF design

Data quality oversight

Regulatory submission readiness

Education

BSc in Computer Science, Mathematics, Statistics or related area

Medidata Rave Study Builder Certification is preferred

Tools

Medidata Rave

Veeva Vault

SQL

Job description

CSL Behring is seeking a Senior EDC Programmer to govern and validate data deliverables, lead EDC setup, and oversee data management systems across in-house, hybrid, and vendor studies. You will partner with Statistics, Data Management, and Standards to assure quality, SDTM/define.xml compliance, and scalable data platforms.

The role supports data automation initiatives, eCRF design, and data integration from external sources, contributing to efficient, regulatory-compliant data processing.