Clinical Programmer - ADAM (Analysis Data Model) and SDTM (Study Data Tabulation Model) with CDISC

5+ years of ADaM, SDTM Implementation Expert with a strong background in statistical programming and clinical data standards.

Support biostatistical analysis by providing ADaM datasets tailored for analysis.

Experience with Gen AI in processing SDTM data and ADaM data analysis.

Strong programming experience with Python, SQL for data handling and automation.

Program and validate derived datasets, statistical tables, listings, and figures (TLFs).

Ensure statistical traceability from raw data to final analysis outputs.

Experience is required in transforming clinical trial data from its raw, collected format (in SDTM - Study Data Tabulation Model)

into ADaM (Analysis Data Model).

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).

Experience with SQL and NoSQL databases such as PostgreSQL, MySQL, and DynamoDB is required.

Excellent to have

Design, train, and fine-tune Generative AI models (LLMs, GANs, VAEs, Diffusion Models).

Design and optimize prompt strategies for LLMs (GPT, Claude, Llama, Mistral, etc.).

Strong understanding of LLMs, diffusion models, and generative techniques.

Require knowledge

Strong knowledge of CDISC standards, FDA guidelines, define.xml.

Ensure security best practices for AWS, Azure applications and infrastructure.

Familiarity with metadata-driven programming.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

5+ years of ADaM, SDTM Implementation Expert with a strong background in statistical programming and clinical data standards.

Support biostatistical analysis by providing ADaM datasets tailored for analysis.

Experience with Gen AI in processing SDTM data and ADaM data analysis.

Strong programming experience with Python, SQL for data handling and automation.

Program and validate derived datasets, statistical tables, listings, and figures (TLFs).

Ensure statistical traceability from raw data to final analysis outputs.

Experience is required in transforming clinical trial data from its raw, collected format (in SDTM - Study Data Tabulation Model)

into ADaM (Analysis Data Model).

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).

Experience with SQL and NoSQL databases such as PostgreSQL, MySQL, and DynamoDB is required.

Excellent to have

Design, train, and fine-tune Generative AI models (LLMs, GANs, VAEs, Diffusion Models).

Design and optimize prompt strategies for LLMs (GPT, Claude, Llama, Mistral, etc.).

Strong understanding of LLMs, diffusion models, and generative techniques.

Require knowledge

Strong knowledge of CDISC standards, FDA guidelines, define.xml.

Ensure security best practices for AWS, Azure applications and infrastructure.

Familiarity with metadata-driven programming.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.