Job
Description
We are seeking an experienced ADaM, SDTM Implementation Expert with a strong background in statistical programming and clinical data standards. The ideal candidate will support biostatistical analysis by providing ADaM datasets tailored for analysis and have experience with python or Gen AI in processing SDTM data and ADaM data analysis. Location: India, Remote Job Type: Full-time Experience Required: 5+ years Job Description: Must Have: 5+ years of experience in ADaM and SDTM implementation. Strong background in statistical programming and clinical data standards. Experience in supporting biostatistical analysis by providing ADaM datasets. Proficiency in Python and SQL for data handling and automation. Ability to program and validate derived datasets, statistical tables, listings, and figures (TLFs). Ensure statistical traceability from raw data to final analysis outputs. Experience in transforming clinical trial data from its raw, collected format (SDTM) into ADaM. Develop and implement SDTM and ADaM datasets in compliance with CDISC standards. Develop and maintain data pipelines, processing semi-structured, structured, and unstructured data. Experience in clinical trial data management and regulatory submissions. Experience with containerization (Docker, ECS, Kubernetes). Proficiency with SQL and NoSQL databases such as PostgreSQL, MySQL, and DynamoDB. Excellent to Have: Experience in designing, training, and fine-tuning Generative AI models (LLMs, GANs, VAEs, Diffusion Models). Ability to design and optimize prompt strategies for LLMs (GPT, Claude, Llama, Mistral, etc.). Strong understanding of LLMs, diffusion models, and generative techniques. Required Knowledge: Strong knowledge of CDISC standards, FDA guidelines, and define.xml. Ensure security best practices for AWS and Azure applications and infrastructure. Familiarity with metadata-driven programming. Knowledge of machine learning or advanced statistical modeling in a clinical research setting. How to Apply: Interested candidates can apply by sending your resume to Shyamala.gunde@excelra.com.
