Hybrid Senior EDC Programmer: Data Quality & Automation

CSL Vifor; Waltham (MA); Hybrid; USD 143,000 - 169,000; Full time

Job summary

CSL Behring is seeking a Senior EDC Programmer to govern and validate clinical data management systems across in-house, hybrid, and vendor-supported studies. You will lead CRF design, database build, and validation activities while aligning with CSL standards and regulatory requirements.

The role partners with Statistics, Data Management, and Standards to enhance data quality, develop scalable data platforms, and pursue AI-enabled automation for efficient data processing.

Qualifications

• 5+ years designing clinical databases in EDC within pharma/CRO
• Experience with in-house, hybrid, and vendor-supported study models
• Familiarity with CDISC standards, CDASH/SDTM, data mapping and submission readiness

Responsibilities

• Drive design, development, and maintenance of clinical study databases with advanced expertise in CRF design, database build, edit checks, and reporting
• Collaborate with cross-functional teams to define data quality methods and validation rules for eCRF and external data sources
• Oversee data quality control frameworks and acceptance criteria for vendor and internal data while ensuring regulatory alignment
• Govern standardized reporting libraries to support study teams across different models
• Oversee setup, automation, and monitoring of recurring data quality and operational reports
• Partner with Data Management, Statistics, and vendors to review and validate deliverables for submission readiness
• Lead reporting solutions to provide data quality and progress insights for decision-making
• Ensure scalable data structures and integration for pooled analyses and traceability
• Support integration of external data sources ensuring data consistency and collaboration with vendors
• Contribute to scalable data platforms and AI-enabled data processing initiatives

Skills

EDC programming

CDASH/SDTM

Medidata Rave

C# programming

Python

R

Data governance

Communication

English fluency

Education

BSc in CS/Math/Stats

Rave Certification

Tools

SAS

Veeva Vault

SQL

Job description

CSL Behring is seeking a Senior EDC Programmer to govern and validate clinical data management systems across in-house, hybrid, and vendor-supported studies. You will lead CRF design, database build, and validation activities while aligning with CSL standards and regulatory requirements.

The role partners with Statistics, Data Management, and Standards to enhance data quality, develop scalable data platforms, and pursue AI-enabled automation for efficient data processing.