EDC Database Programming Lead — Data Strategy & Delivery

Daiichi Sankyo Co.; Basking Ridge (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Daiichi Sankyo Co. is seeking a Manager, EDC Database Programming to lead overseen study build activities for all clinical studies. The role covers design, build, edit checks, and custom function programming, with collaboration across Biostatistics, Data Management, CROs, and external partners.

The ideal candidate has 5+ years in EDC programming, strong knowledge of CDISC/CDASH standards, and experience coordinating QMS changes. This on-site position located in the U.S.

Qualifications

• Minimum of 5 years of EDC study build and database programming experience in the device/pharmaceutical/CRO industry.
• Expertise in Clinical Programming, methods, and techniques.
• Knowledge of industry standard clinical technologies including CTMS, EDC, CDASH and CDISC data standards.

Responsibilities

• Review study build designs for fit with eCRF specifications and standards.
• Lead testing, edit checks, and custom function development for study builds.
• Coordinate with CROs and service providers to ensure timely, high-quality builds.
• Oversee change control processes and risk assessments for study build changes.
• Monitor issues and drive continuous improvement in study build processes.

Skills

EDC programming

Study build

Data validation

Clinical programming

Project management

Education

Bachelor's Degree in Life Sciences

Master's Degree preferred

Tools

RAVE

eCRF systems

Job description

Daiichi Sankyo Co. is seeking a Manager, EDC Database Programming to lead overseen study build activities for all clinical studies. The role covers design, build, edit checks, and custom function programming, with collaboration across Biostatistics, Data Management, CROs, and external partners.

The ideal candidate has 5+ years in EDC programming, strong knowledge of CDISC/CDASH standards, and experience coordinating QMS changes. This on-site position located in the U.S.