ML Engineer – Data Science

Job Summary

We are seeking an ML engineer with experience in developing and deploying AI-powered agents for Dats Science and Statistical Programming environment in CRO/Pharma or Biotech industry. The ideal candidate will combine expertise in Large Language Models (LLMs), and statistical programming to automate clinical trial workflows, improve operational efficiency, and support data-driven decision-making.

Key Responsibilities

• Design and develop AI Agents and AI Copilots for Statistical Programming, and Biostatistics functions.
• Build intelligent workflows to automate SAS programming, clinical reporting, data validation, and documentation tasks.
• Develop and integrate LLM-based solutions to assist programmers in code generation, review, debugging, and optimization.
• Collaborate with Data Science team and Business Stakeholders to gather requirements.
• Create AI solutions for SDTM, ADaM, TLF generation, clinical study reports, and regulatory submission support.
• Develop Retrieval-Augmented Generation (RAG) systems using clinical and regulatory knowledge repositories.
• Integrate AI agents with SAS, Python, clinical databases, and enterprise applications.
• Ensure compliance with GxP, FDA, EMA, and data privacy regulations.
• Monitor, evaluate, and improve AI agent performance, accuracy, and reliability.
• Prepare technical documentation, validation plans, and deployment artifacts.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Computer Science, Data Science, Statistics or a related field.
• 3+ years of experience in AI/ML development, software development, or pharmaceutical analytics.
• Strong programming skills in Python.
• Working knowledge of SAS Programming
• Experience with Large Language Models (LLMs), Generative AI, and AI Agent frameworks.
• Knowledge of prompt engineering, RAG architecture, vector databases, and AI orchestration frameworks.
• Strong analytical and problem-solving skills.

Preferred Qualifications

• Exposure to Biostatistics and Statistical Programming projects.
• Experience with AI frameworks such as LangChain, LangGraph, CrewAI, AutoGen, or similar technologies.
• Knowledge of cloud platforms such as AWS, Azure, or GCP.
• Familiarity with MLOps and AI governance practices.

Experience:

• ML Engineering: 3 years (Preferred)

Work Location: Remote