Senior EDC Programmer - Data Quality & AI (Hybrid)

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

Job summary

CSL Behring seeks a Senior EDC Programmer to govern, validate, and lead the setup and maintenance of clinical data management systems across in‑house, hybrid, and vendor studies. You will drive eCRF design, data quality rules, and validation libraries while collaborating with Statistics, Data Management, and vendor teams to ensure submission readiness and regulatory compliance.

The role emphasizes scalable data platforms, AI-enabled automation, and advancing data capabilities for efficient

Qualifications

• 5+ years of relevant experience with clinical database design in EDC systems within a pharmaceutical or CRO environment.
• Exposure to in‑house, hybrid, and/or vendor‑supported study models.
• Familiarity with CDISC standards, particularly CDASH, SDTM including data mapping, validation, and activities supporting submission readiness.
• Proficiency with EDC systems (Medidata Rave, Veeva Vault) and understanding of eCRF design and clinical data collection frameworks.
• Strong understanding of clinical data processes, including data standards, data flows, and integration of eCRF and external data sources, data quality oversight, validation processes, and vendor deliverable review.
• Ability to manage priorities, meet timelines in a fast-paced environment.
• Experience with data migration activities for post-production study changes is preferred.
• Experience with C# is preferred and familiarity with SAS, Python, or R is a plus.

Responsibilities

• Drive design, development, and maintenance of clinical study databases including CRF design, database build, edit check programming, report development, and system interface configuration.
• Collaborate with cross-functional teams to define data quality methods, validation rules for eCRF and external data sources.
• Oversee data quality control frameworks, including validation libraries and acceptance criteria for vendor and internal data.
• Govern a library of reports and listings to support study teams with consistency and efficiency.
• Oversee setup, automation, and monitoring of recurring data quality and operational reports across models.
• Partner with Data Management, Statistics, and vendors to review and validate data deliverables for regulatory submission readiness.
• Lead reporting solutions for data quality, study progress, and key metrics.
• Ensure data structures and integration approaches support pooled analyses and traceability.
• Support integration and governance of external data sources, enabling collaboration with vendors.
• Contribute to innovation by supporting scalable data platforms and AI-enabled capabilities.

Skills

CDASH/SDTM

eCRF design

Medidata Rave

Veeva Vault

C#

SAS

Python

R

Data governance

Data quality

Regulatory knowledge

English communication

Education

BSc in Computer Science/Math/Stats

Medidata Rave Study Builder Certification

Tools

Medidata Rave

Veeva Vault

Job description

CSL Behring seeks a Senior EDC Programmer to govern, validate, and lead the setup and maintenance of clinical data management systems across in‑house, hybrid, and vendor studies. You will drive eCRF design, data quality rules, and validation libraries while collaborating with Statistics, Data Management, and vendor teams to ensure submission readiness and regulatory compliance.

The role emphasizes scalable data platforms, AI-enabled automation, and advancing data capabilities for efficient