Teams at ClinChoice

Supports clinical trial statistical programming under senior guidance, including developing and validating datasets, tables, figures, listings, and CDISC-compliant regulatory submission deliverables. Uses SAS and/or R to process clinical data, contribute to SDTM and ADaM datasets, maintain specifications and documentation, perform quality checks, and resolve programming issues. Collaborates with biostatisticians, data managers, and cross-functional teams while developing expertise in clinical research standards and statistical programming.

Manage the development, implementation, operation, monitoring, and assessment of REMS and U.S. risk management programs. Coordinate governance, stakeholders, vendors, budgets, compliance documentation, audits, CAPAs, FDA correspondence, reporting, risk mitigation, and inspection readiness. Support launches, program transitions, operational inquiries, and effectiveness assessments while maintaining controlled workflows and regulatory records.

Leads statistical programming for clinical trials, developing and reviewing SAS programs, datasets, tables, listings, and figures. Supports SDTM/ADaM standards and regulatory submissions, reviews specifications and outputs, manages deliverables and timelines, collaborates with clinical teams, and provides technical guidance and mentorship to statistical programmers. Requires strong knowledge of clinical development, CDISC, ICH, Good Clinical Practices, and regulatory requirements.