Senior EDC Programmer – Data Quality & Automation

BioSpace; King of Prussia (PA); 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 deliverables, ensuring alignment with CSL standards and regulatory requirements. The role oversees study databases, data quality frameworks, and cross-functional collaboration across Statistics, Data Management, and Standards in a hybrid work setting.

You will contribute to scalable data platforms, automation strategies, and AI-enabled capabilities to enhance data processing and analytics in

Qualifications

• 5+ years of relevant experience with clinical database design in EDC systems.
• Familiarity with CDISC standards, particularly CDASH/SDTM including data mapping, validation and submission readiness.
• Proficiency with EDC systems (Medidata Rave, Veeva Vault) and understanding of eCRF design.
• Ability to manage priorities and deadlines in a fast-paced, evolving environment.
• Experience with data migration activities for post-production study changes is preferred.
• Fluent in English; strong communication skills.

Responsibilities

• Drive design, development, and maintenance of clinical study databases using CRF design, database build, edit checks, and reporting.
• Collaborate with clinical study teams and cross-functional stakeholders to define and enhance data quality methods and 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 and maintain a standardized library of reports and listings for study teams across different models.
• Oversee setup, automation, and monitoring of recurring data quality and operational reports to ensure accuracy and timely outputs.
• Partner with Data Management, Statistics, and vendors to review and validate clinical data deliverables for submission readiness.
• Lead reporting solutions to provide insights into data quality and study progress.
• Ensure data structures and integration approaches support pooled analyses and traceability of current and legacy data.
• Support integration of external data sources (IxRS, eDiaries, labs, ECG) and collaboration with internal teams and vendors.
• Contribute to future-state initiatives with scalable data platforms and AI-enabled capabilities.

Skills

Communication

Planning & Organization

English fluency

Matrix organization

Networking

Education

BSc in Computer Science/Math/Stats

Medidata Rave Study Builder Certification

Tools

Medidata Rave

Veeva Vault

C#

SAS

Python

R

Job description

CSL Behring is seeking a Senior EDC Programmer to govern and validate clinical data management deliverables, ensuring alignment with CSL standards and regulatory requirements. The role oversees study databases, data quality frameworks, and cross-functional collaboration across Statistics, Data Management, and Standards in a hybrid work setting.

You will contribute to scalable data platforms, automation strategies, and AI-enabled capabilities to enhance data processing and analytics in