Teams at Cytel

Leads complex clinical trial statistical programming using SAS, including TLFs, SDTM and ADaM datasets, Define.xml, regulatory submissions, documentation, quality control, and global utility development. Provides technical and project leadership, ensures compliance with SOPs and FDA/ICH/GCP regulations, supports interactions with regulators and external partners, and independently briefs management on progress and issues.

Leads biomedical data science for clinical and health research, integrating clinical, observational, EHR, genetic, wearable, electrophysiological, and video data. Develops signal-processing methods, machine-learning models, probabilistic and time-series analyses, scalable data pipelines, and reproducible workflows. Validates clinically relevant models, supports disease phenotyping and predictive modeling, ensures compliance with pharmaceutical and healthcare standards, and communicates technical findings to clients and stakeholders.

Provides statistical support for Phase I–IV clinical studies, including study design, sample size calculations, protocol development, CRF and data review, SAPs, ADaM specifications, statistical analyses, clinical study reports, and regulatory submissions. Collaborates with clinical, regulatory, programming, pharmaceutical, and biotechnology teams while explaining statistical methods and results to stakeholders.