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2 weeks ago
This role involves developing synthetic clinical and operational datasets using Python frameworks to support data-driven decision making.
- Create high-quality, audit-ready datasets that reduce reliance on production data, accelerate testing cycles, and ensure compliance with FDA, EMA, and global regulatory standards.
Key Responsibilities include:
- Designing and implementing AI/ML models for realistic clinical scenario simulation.
- Developing connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
- Ensuring adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards.
The ideal candidate will have:
- Strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow).
- Familiarity with clinical data management systems (Medidata Rave, Veeva CDB, Oracle InForm).
- Knowledge of GxP/21 CFR Part 11 and regulated data handling.
As a key member of our team, you will contribute to the development of innovative solutions that drive business growth and improve patient outcomes. Enjoy a collaborative work environment and opportunities for professional growth and development.
OthersDo not hesitate to apply if you are passionate about harnessing the power of AI/ML to transform the way we manage clinical data.
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