Clinical Database Programmer

Responsibilities:

Develops database design specifications/definitions in consultation with data management, statistics and programming.

Designs and creates clinical databases.

Programs and tests edit checks within the database.

Programs and tests derivation procedures (derive values) within the database.

Programs and tests reports using SQL/SAS to identify inconsistencies and support data review efforts.

Contributes to solutions for routine technical problems and liaises with ITS as appropriate to resolve issues.

Identifies and understands the need for standardization and takes initiative to help improve departmental efficiency.

Maintains all required study documentation.

Requirements:

BA / BS computer science/information technology or life sciences from a 4 year accredited university.

Minimum 3 years clinical database programming experience preferred in the device / pharmaceutical / CRO industry.

Experience with one or more leading EDC system is desired.

Proficient computer skills across multiple applications

SQL scripting required.

Understanding of relational databases.

Basic Knowledge of CDISC/CDASH preferred.

Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required.

Ability to work independently with minimal supervision and manage multiple deliverables concurrently.

Ability to ensure clinical database programming work is completed in a consistent manner and validated according to department practices.

Excellent interpersonal skills, strong written and verbal communication skills.

Working knowledge of clinical development.

Working understanding of techniques of clinical trial principles.

Ability to interact effectively within and across team environment.