Statistical Programmer II

OVERVIEW Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high-quality statistical programming outputs. Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions. Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation. Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables. Use of R and AI tools to augment, enhance day to day programming is a huge plus. KEY TASKS & RESPONSIBILITIES ➢ Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables. ➢ Create specifications and SAS programs for ADaM datasets supporting trial-level reporting and integrated safety and efficacy analyses. ➢ Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and Statistical Analysis Plans (SAPs). ➢ Program and QC data listings, summaries, graphs, and statistical models as req...