Description

You will lead end-to-end clinical data workflows, regulatory submissions, and modern data platform transformations in GxP-regulated environments.

This role is on-site.

Responsibilities

• Lead clinical data programming and platform architecture for regulatory submissions.
• Transform legacy clinical data systems into cloud-based analytics platforms.
• Ensure strict compliance with GxP frameworks and global regulatory standards.
• Develop and maintain statistical programming solutions using SAS, Python, and R.
• Design data structures adhering to CDISC standards for SDTM and ADaM.

Required Skills

• 15+ years of experience in statistical programming and clinical data management.
• Expert-level proficiency in SAS (Base, Macro, SQL, ODS, STAT, Graph).
• Deep knowledge of CDISC standards (SDTM, ADaM, define.xml).
• Hands-on experience with Python (Pandas) and/or R (admiral, Shiny).
• Proven experience with cloud platforms AWS or Azure.
• Strong understanding of GxP and clinical compliance frameworks.
• Experience with XML processing and regulatory submission workflows.

Preferred Skills

• Bachelor’s or Master’s degree in Computer Science, Statistics, Life Sciences, or related field.

Key Skills

Education

Bachelor's or Master's degrees