Teams at Cytel

Designs, develops, and deploys secure, scalable AI solutions for Statistical Programming workflows. Builds Generative AI, RAG, and agentic applications involving ingestion, retrieval, code generation, validation, and human review. Develops reusable services and APIs while implementing traceability, reproducibility, evaluation, regression testing, monitoring, and LLMOps practices. Collaborates with programming, architecture, IT, security, validation, and governance teams to move AI proofs of concept into production, regulated environments.

Provides expert leadership and oversight of CDISC standards across clinical studies and regulatory submissions. Reviews SDTM and ADaM datasets, annotated CRFs, define.xml files, Reviewer's Guides, and submission packages for compliance, traceability, and quality. Advises cross-functional teams and CROs, supports standards governance, develops documentation and training, mentors programmers, and improves global programming processes and submission readiness.

Lead statistical activities for Phase II–III clinical trials from protocol design through reporting. Responsibilities include SAP development, sample size calculations, statistical analysis, TLF review, database lock and submission support, regulatory responses, vendor oversight, and cross-functional collaboration. Use SAS and/or R for analyses, modeling, simulation, exploratory work, and quality control. Coordinate statistical activities across studies and apply adaptive, group sequential, count-data, machine learning, and deep learning methods.