Statistical Programmer

POSITION SUMMARY

DUTIES

• Develop, execute, test, validate, and maintain SAS and/or R programs supporting clinical and nonclinical analyses, including reusable scripts, macros/functions, tables, figures, listings, reports, and visualizations
• Support SDTM-to-ADaM and individual-study-to-ISS traceability, safety analyses, and customized analytical requests involving adverse events, laboratory data, demographics, disposition, treatment exposure, vital signs, and other study data.
• Work with FDA-supported analytical environments and tools such as SAS/SARGE, R/R Shiny, JMP/JMP Clinical, Analysis Studio/Toolbox, MAED, SEND Explorer, and DataFit, as applicable to the assigned service.
• Perform programming QC and verification of source data, transformations, calculations, statistical logic, and outputs; investigate discrepancies, unexpected results, and data-quality issues.
• Maintain complete reproducibility and auditability by documenting datasets, versions, scripts, parameters, processing steps, assumptions, validation results, and final outputs.
• Collaborate with biostatisticians, clinical/nonclinical data standards specialists, data managers, scientific reviewers, and other stakeholders to translate analytical requirements into validated programming solutions.
• Contribute to automation, standardization, reusable programming assets, technical documentation, and continuous improvement of recurring analytical workflows.

EDUCATION

REQUIRED QUALIFICATIONS

• 5+ years of statistical programming experience in pharmaceutical, biotechnology, CRO, regulatory, public-health, or other regulated life-sciences settings.
• Strong hands-on SAS and/or R programming experience, including data manipulation, statistical analyses, production programming, debugging, QC, and validation.
• Experience working with CDISC standards and clinical-trial data; practical knowledge of SDTM and ADaM required, with SEND and/or ISS experience strongly preferred.
• Ability to interpret analysis specifications and translate them into accurate, efficient, well-documented, and reproducible programs and outputs.
• Strong attention to data integrity, traceability, documentation, quality control, and delivery in regulated or quality-managed environments.
• Must be able to obtain and maintain a High-Risk Public Trust or equivalent federal client access. This role supports sensitive federal programs and involves elevated access to systems and data.
• Position requires the current ability to obtain and maintain required access without interruption in alignment with long-term program needs.
• Must be authorized to work in the United States without employer sponsorship now or in the future.

PREFERRED QUALIFICATIONS

• Experience with FDA/CDER review workflows or regulatory submissions; FDA study-data guidance and validation rules; safety analyses; MedDRA and controlled terminology; JMP/JMP Clinical, MAED, Analysis Studio, SARGE, DataFit, SEND Explorer, or R Shiny; and development of automated or reusable analytical workflows

ABOUT APV