Python Developer

Position Type:
Contract
Remote

Required:

• Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development
• Strong understanding of SDTM standards and CDISC requirements.
• Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms).
• Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures.
• Excellent problem-solving and collaboration skills.
• Experience working with clinical trial datasets (ADaM, SDTM, raw).
• Prior work on automation frameworks or metadata-driven data pipelines.
• Knowledge of regulatory submission processes and FDA expectations for e-submissions.
• Must already be familiar with SDTM/CDISC clinical data standards
• Must have pharma environment/industry experience.
• Previous experience implementing scalable AI solutions is ideal

• Design and develop automation pipelines for SDTM dataset generation using Python.
• Build and deploy AI/ML models to streamline data mapping, domain identification, and controlled terminology matching.
• Automate metadata-driven data transformations based on CDISC/SDTM standards.
• Collaborate with cross-functional teams (clinical programming, data management, biostats) to gather requirements and ensure regulatory compliance.
• Create reusable Python libraries and tools to support automation across multiple studies.
• Implement validation checks, quality controls, and audit trails to ensure SDTM compliance and traceability.
• Stay current with CDISC standards, regulatory guidelines (e.g., FDA), and AI/ML best practices.