Statistical Programmer

POSITION SUMMARY

APV is seeking an experienced Statistical Programmer to support clinical and nonclinical regulatory analytics for the FDA Center for Drug Evaluation and Research (CDER), Office of Computational Science (OCS). The role focuses on hands-on development, execution, validation, and maintenance of reproducible statistical programs and reviewer-ready analytical outputs using standardized clinical and nonclinical study data, including CDISC SDTM, ADaM, Integrated Summary of Safety (ISS), and SEND. Candidates may bring relevant experience from FDA, pharmaceutical/biotechnology companies, CROs, consulting organizations, or other regulated life-sciences environments.

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

Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative discipline.

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