Generate and validate CDISC SDTM and ADaM datasets related to noncompartmental analysis (NCA), including PC/PP, ADPC, ADPP, and other relevant domains.
Develop submission-ready datasets that comply with CDISC standards, implementation guides, and controlled terminology.
Perform dataset validation using Pinnacle 21 (Community and/or Enterprise) and resolve validation findings to ensure regulatory compliance.
Prepare and maintain Define-XML packages and supporting metadata for regulatory submissions.
Develop and maintain programming code using R and/or SAS to create, validate, and QC clinical datasets.
Perform quality control (QC) of datasets, programming outputs, and submission documentation to ensure accuracy, completeness, and consistency with source data.
Support regulatory submissions to agencies such as the FDA, PMDA, and EMA by producing high-quality, submission-ready datasets and documentation.
Requirements
Bachelor’s degree in quantitative sciences, biostatistics, statistics, engineering, data science, or similar field. Master’s degree preferred.
Experience generating and validating CDISC SDTM and ADaM NCA domains (e.g., PC/PP, ADPC, ADPP, and related datasets).
Proficiency with Pinnacle 21 (Community and/or Enterprise) for validation.
Proficiency with R or SAS.
Experience preparing or reviewing Define-XML (define packages) for regulatory submissions.
Strong understanding of CDISC standards, controlled terminology, and implementation guides.
Experience supporting regulatory submissions (FDA, PMDA, or EMA) is preferred.
Strong attention to detail and ability to work independently in a collaborative environment.
This position is ideal for someone with hands-on experience in clinical data standards who can efficiently produce submission-ready datasets and associated documentation for NCA analyses.