PYTHON AI ENGINEER

Title : PYTHON AI ENGINEER - Automated Test Data Generation

Location: Remote (India)Timing: 06:30 PM to 03:30 PM IST

Overview

We are seeking a Python AI Engineer with expertise in synthetic and automated test data generation to support clinical trials, regulatory submissions, and GxP-compliant systems across the life sciences domain. This role will focus on building intelligent frameworks that generate high-quality, audit-ready datasets for use in clinical data management (CDM), biostatistics, pharmacovigilance, and regulatory validation environments.By leveraging AI/ML techniques and Python-based automation, this role will help reduce dependency on production data, accelerate testing cycles, and ensure compliance with stringent regulatory requirements (FDA, EMA, ICH E6, 21 CFR Part 11).

Required Skills & Qualifications

• Strong proficiency in Python (pandas, NumPy, scikit-learn, PyTorch/TensorFlow, LangChain, etc.).
• Experience generating synthetic clinical trial data or working with CDISC standards (SDTM, ADaM, Define-XML).
• Familiarity with clinical data management systems (Medidata Rave, Veeva CDB, Oracle InForm, etc.) and testing needs.
• Understanding of GxP/21 CFR Part 11 compliance and regulated data handling.
• Knowledge of test automation frameworks (PyTest, Robot Framework) and data validation tools (e.g., Pinnacle21).
  

Preferred Qualifications

• Experience supporting clinical trial systems (EDC, CTMS, PV, LIMS, eCOA).
• Understanding of statistical programming workflows (SAS, R) and integration with test data pipelines.
• Hands-on experience with cloud platforms (AWS, Azure, GCP) for secure AI/ML deployment.
• Familiarity with inspection readiness and validation documentation in a pharma context.
  

Skills: gxp,automation,clinical data management,ml,test data,python,clinical data