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Rbw Consulting

AD, Stat Programmer

Rbw Consulting, San Diego, California, United States, 92189


Position : Associate Director, Stat ProgrammerLocation : San Diego, CA (On-Site)Type : Full-timeResponsibilities :Lead statistical programming activities, ensuring high-quality delivery across clinical programs.Oversee vendor management for statistical programming deliverables (SDTM, ADaM, TFLs).Provide technical leadership for internal programming tasks to support clinical development.Collaborate with cross-functional teams, providing expertise in statistical programming.Manage and maintain programming infrastructure, including macro libraries, scripts, and tools.Ensure compliance with data standards and contribute to process improvements.Develop and implement best practices for programming efficiency and effectiveness.Qualifications :Bachelor's degree or higher in Statistics, Mathematics, Computer Science, or related field.12+ years of experience in clinical SAS programming within the pharmaceutical/biotech industry.Proficient in SAS programming (SAS/MACRO, SAS/SQL, SAS/GRAPH, etc.).Deep knowledge of CDISC standards, including SDTM and ADaM.Experience with regulatory submission packages (define.xml, cSDRG, ADRG).Strong understanding of medical dictionaries (MedDRA, WHODrug) and clinical data management.Experience with rare diseases and managing CROs/Biostats vendors preferred.