
AI-Driven Synthetic Data Generation Specialist
12 hours ago
We are seeking a Python AI Engineer to design and implement intelligent frameworks for synthetic test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems. This role will leverage AI/ML and Python automation to deliver high-quality, audit-ready datasets that reduce reliance on production data, accelerate testing cycles, and ensure compliance with FDA, EMA, and global regulatory standards.
Job Description:
The ideal candidate will have expertise in designing and developing synthetic data generation frameworks using Python, leveraging AI/ML techniques such as generative adversarial networks (GANs), variational autoencoders (VAEs), and diffusion models. They will work closely with cross-functional teams to gather requirements, develop and maintain the synthetic data pipeline, and collaborate with stakeholders to ensure seamless integration into CI/CD pipelines, trial simulations, and automated validation environments.
Key Responsibilities:
- Develop and maintain synthetic data generation frameworks using Python, incorporating AI/ML techniques such as GANs, VAEs, and diffusion models.
- Collaborate with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to gather requirements and ensure alignment with regulatory standards.
- Design and implement connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
- Partner with SMEs to validate AI-generated datasets for regulatory acceptability.
Requirements:
- Mastery of Python programming language, including experience with libraries such as TensorFlow, PyTorch, or Keras.
- Expertise in AI/ML techniques, including GANs, VAEs, and diffusion models.
- Familiarity with clinical trials, regulatory submissions, and GxP-compliant systems.
- Strong collaboration and communication skills, with ability to work effectively with cross-functional teams.
Benefits:
This role offers the opportunity to work at the forefront of AI/ML innovation in the pharmaceutical industry, with a focus on delivering high-quality, compliant datasets that accelerate testing cycles and ensure regulatory acceptance. You will be part of a dynamic team that values collaboration, innovation, and continuous learning.
About Us:
We are a leading provider of innovative solutions for the pharmaceutical industry, with a commitment to excellence, integrity, and customer satisfaction. We are dedicated to helping our clients succeed in a rapidly changing regulatory environment, while maintaining the highest standards of quality, safety, and compliance.
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