Tools & Standards Lead, Raleigh, NC

UCB•Raleigh, NC

6d•Hybrid

About The Position

The Statistical Computing Environment (SCE) Lead (Tools & Standards Lead) is accountable for the strategy, governance, compliance, adoption, and continuous evolution of the organization's Statistical Computing Environment. The role ensures the platform provides a validated, scalable, secure, and innovative environment that enables efficient evidence generation, regulatory compliance, and modern analytics across clinical development.

Requirements

Deep understanding of clinical development life cycle, statistical programming, and regulatory requirements.
Experience with validated computing environments, cloud platforms, software validation, and quality systems.
Strong leadership, stakeholder management, communication, and change management skills.
Work across stakeholder groups to achieve consensus and ensure standards are consistently applied.
Interact with management teams to coordinate activities, align priorities, and facilitate timely decisions.
Effectively balance multiple high-priority project needs while maintaining strong project management, communication, and organizational skills.
Knowledge of SAS, R, Python, Git, DevOps, AI-enabled workflows, and modern analytics platforms.

Nice To Haves

Knowledge of Domino Data Lab is preferred.

Responsibilities

Own the vision, roadmap, and governance of the Statistical Computing Environment.
Act as the primary business owner for the platform
Partner with Biometrics, Data Science, IT, Quality, and external vendors to ensure platform reliability, compliance, and business value.
Ensure GxP compliance, validation, inspection readiness, and data integrity requirements.
Translate clinical analysis and reporting requirements into scalable platform capabilities supporting regulatory submissions and evidence generation.
Drive adoption of modern technologies, including automation, AI, open-source tools, and DevOps practices.
Lead platform enhancements, change management, training, and user support activities for biometrics and other data science communities.
Establish standards for reproducibility, traceability, auditability, and metadata-driven analytics.
Promote continuous improvement and innovation to increase efficiency, quality, and user experience.
Represent the organization in industry forums and contribute to the evolution of statistical computing and data science practices.