Lead Principal Programmer – Clinical Trials & Compliance

UCB Inc.; Raleigh (NC); Hybrid; USD 150.000 - 210.000; Vollzeit

Zusammenfassung

UCB is seeking a Senior Principal Programmer (Statistical Computing Environment Business Coordinator) to join the Programming, Visualization and Reporting team in Raleigh, NC or Atlanta, GA. The role focuses on enabling teams to operate within UCB's modern Statistical Computing Environment and delivering compliant, well-governed study setups.

You will translate clinical reporting needs, manage access and configurations, and support onboarding, validation, and lifecycle improvements,

Qualifikationen

• 5+ years of experience in clinical trial results generation, reporting, and submission processes.
• Experience with Statistical Computing Environments, including access management and biometrics requirements.
• Knowledge of CDISC standards (SDTM/ADaM) and Tables, Figures, and Listings.
• Experience in regulated pharmaceutical environments, SDLC, validation, audit readiness, and compliant configurations.
• Ability to communicate with technical teams and business stakeholders while tracking setup across systems.
• Experience with Domino Data Lab, SAS, R, Git, Azure DevOps, VS Code, or SAS Studio.

Aufgaben

• Review and coordinate analysis and reporting setup requests for clinical trials.
• Configure study structures, repositories, datasets, reporting components, and access per CDISC governance.
• Manage role-based access, study configurations, and Git/Azure DevOps resources.
• Coordinate environment provisioning so study teams can begin work in a ready and reliable environment.
• Support onboarding and ongoing operations as a first-line technical contact.
• Improve lifecycle management and workflows by documenting processes and automating practical solutions.

Kenntnisse

Clinical trial reporting

Communication with stakeholders

Regulatory compliance

Cross-functional collaboration

Documentation & validation

Tools

Domino Data Lab

SAS

R

Git

Azure DevOps

VS Code

SAS Studio

Jobbeschreibung

UCB is seeking a Senior Principal Programmer (Statistical Computing Environment Business Coordinator) to join the Programming, Visualization and Reporting team in Raleigh, NC or Atlanta, GA. The role focuses on enabling teams to operate within UCB's modern Statistical Computing Environment and delivering compliant, well-governed study setups.

You will translate clinical reporting needs, manage access and configurations, and support onboarding, validation, and lifecycle improvements,