Teams at Cytel

Develop automation and AI solutions supporting pharmaceutical clinical trials. Interpret requirements, identify workflow improvements, build proof-of-concept tools using R, Shiny, and LLM-supported coding, and mature successful prototypes into validated, documented, reusable solutions. Collaborate with statisticians, programmers, data scientists, and AI leads while ensuring testing, traceability, audit trails, version control, and compliance with regulated clinical development expectations.

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.

Provides executive scientific and strategic leadership in quantitative clinical pharmacology consulting. Leads Pop-PK, PK-PD, NCA, MIDD, regulatory strategy, trial design, and quantitative decision-making engagements. Develops thought leadership, manages major client relationships, supports business development, mentors quantitative teams, and collaborates with statisticians, software teams, business developers, and data scientists. The role also involves regulatory authority engagement, technical oversight, publications, presentations, and client travel.