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A2 Ai

2 jobs near Columbus, OH

A2 Ai

Statistical Programmer

Ann Arbor, MI · On-site

$75 - $110/hr

* 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 ...

A2 Ai

Statistician

Ann Arbor, MI · On-site

$75 - $95/hr

* Analyze and aggregate large-scale pharmacological and clinical datasets to ensure integrity and usability for drug development. * Perform exploratory data analysis, including cleaning, organization ...

Statistical Programmer

A2 Ai

Ann Arbor, MI • On-site

$75 - $110/hr

Other

Posted 4 days ago

Job description

  • 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.
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