Sr. Statistical Programmer

Responsibilities :

• Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs.
• Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and client deliverables.
• Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis-ready datasets and outputs.
• Act as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast-paced environment.
• Conduct independent QC and peer review of programming deliverables, ensuring accuracy, compliance, and reproducibility of results.
• Develop and maintain study-specific programming specifications, documentation, and macros to streamline programming efficiency.
• Support regulatory submission readiness, including , reviewer's guides, and response to agency questions.
• Proactively identify and resolve data or programming issues that may impact timelines or analysis accuracy.
• Mentor and support junior programmers, fostering quality, consistency, and CDISC best practices across projects.
• Contribute to process improvement initiatives and template development for a growing statistical programming team.

Requirements :