AI Innovator

4 days ago

Solapur, Maharashtra, India beBeeAI Full time ₹ 10,00,000 - ₹ 15,00,000
We are seeking a highly skilled Python AI Engineer to design and implement intelligent frameworks for synthetic and automated test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.Key Responsibilities
  • Develop robust Python frameworks to generate synthetic clinical and operational datasets, ensuring adherence to CDISC standards.
  • Produce high-quality, CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
  • Simulate domain-specific datasets (adverse events, labs, demographics, drug exposure) with variability and referential integrity, while maintaining clinical and statistical fidelity.
  • Implement connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows, ensuring seamless integration.
  • Apply generative AI (LLMs, GANs, diffusion models) to model realistic clinical scenarios, leveraging cutting-edge technology to drive innovation.
  • Create synthetic patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems, providing a comprehensive view of the clinical trial process.
  • Use AI-driven automation to simulate rare or complex cases for stress and edge-case testing, ensuring thorough validation and quality assurance.
  • Ensure strict adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards, maintaining the highest level of data integrity and security.
  • Implement anonymization/obfuscation techniques while preserving clinical and statistical fidelity, ensuring that sensitive information is protected.
  • Produce detailed validation protocols and documentation for audit and inspection readiness, providing transparency and accountability.
  • Collaborate closely with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to gather requirements and ensure alignment with business objectives.
  • Embed test data generation into CI/CD pipelines, trial simulations, and automated validation environments, streamlining the development process and enhancing efficiency.
  • Partner with Subject Matter Experts (SMEs) to validate AI-generated datasets for regulatory acceptability, ensuring compliance with industry standards.

Required Skills & Qualifications:

  • Strong expertise in Python programming, including proficiency in pandas, NumPy, scikit-learn, PyTorch/TensorFlow, and LangChain.
  • Hands-on experience generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML).
  • Familiarity with clinical data management systems (Medidata Rave, Veeva CDB, Oracle InForm).
  • Knowledge of GxP/21 CFR Part 11 and regulated data handling.
  • Experience with test automation frameworks (PyTest, Robot Framework) and validation tools (Pinnacle21).

Preferred Qualifications:

  • Background supporting clinical trial systems (EDC, CTMS, PV, LIMS, eCOA).
  • Understanding of statistical workflows (SAS, R) and integration into test pipelines.
  • Cloud experience (AWS, Azure, GCP) for secure AI/ML deployment.
  • Experience with inspection readiness and validation documentation in pharma.

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