Statistical Programmer – Regulatory Analytics (CDISC)

Jimmy Jazz; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

APV is seeking an experienced Statistical Programmer to support regulatory analytics for the FDA CDER, Office of Computational Science. The role focuses on hands-on development, execution, validation, and maintenance of reproducible statistical programs using SDTM, ADaM, ISS, and SEND.

You will work with SAS and R, ensuring traceability, documentation, and collaboration with biostatisticians and data managers in a regulated environment. Strong adherence to data integrity is essential.

Qualifications

• 5+ years of statistical programming experience in regulated life-sciences settings.
• Strong SAS and/or R programming experience, including data manipulation, production programming, QC, and validation.
• Experience with CDISC standards and clinical-trial data; SDTM and ADaM required, with SEND/ISS preferred.
• Ability to interpret analysis specifications and translate them into reproducible programs and outputs.
• Strong attention to data integrity, traceability, documentation, and quality control in regulated environments.

Responsibilities

• Develop, execute, test, validate, and maintain SAS and/or R programs for analyses, tables, figures, listings, and reports.
• Support SDTM-to-ADaM and ISS traceability and safety analyses.
• Work with FDA-supported analytical environments and tools (SAS/SARGE, R Shiny, JMP Clinical, etc.).
• Perform programming QC and investigate discrepancies and data-quality issues.
• Document datasets, versions, scripts, parameters, processing steps, validation results, and outputs.
• Collaborate with biostatisticians, data standards specialists, data managers, and stakeholders to translate requirements.
• Contribute to automation, standardization, and reusable analytical workflows.

Skills

Statistical programming

SAS programming

R programming

CDISC standards

Data integrity

Education

Bachelor’s degree in quantitative field

Tools

SAS/SARGE

R Shiny

JMP Clinical

Analysis Studio/Toolbox

MAED

SEND Explorer

DataFit

Job description

APV is seeking an experienced Statistical Programmer to support regulatory analytics for the FDA CDER, Office of Computational Science. The role focuses on hands-on development, execution, validation, and maintenance of reproducible statistical programs using SDTM, ADaM, ISS, and SEND.

You will work with SAS and R, ensuring traceability, documentation, and collaboration with biostatisticians and data managers in a regulated environment. Strong adherence to data integrity is essential.