Python Developer

Job Description

Job Summary:

• We are seeking a talented Python Developer with experience in clinical data standards (SDTM/CDISC) and a passion for AI/ML-driven automation.
• In this role, you will design and implement scalable solutions to automate the transformation of raw clinical trial data into SDTM-compliant datasets, reducing manual effort and increasing efficiency.

Duties and Responsibilities:

• 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.

Education and Experience:

• Master’s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development.
• Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms).
• Experience working with clinical trial datasets (ADaM, SDTM, raw).

Knowledge, Skills and Abilities:

• Strong understanding of SDTM standards and CDISC requirements.
• Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures.
• Excellent problem-solving and collaboration skills.
• Prior work on automation frameworks or metadata-driven data pipelines.
• Knowledge of regulatory submission processes and FDA expectations for e-submissions.