Clinical Research

• Lead Phase II-III clinical studies across the region, providing statistical and development support and influence for client's trials.
• Formulate integrated analytical approaches to mine data sources and employ statistical methods, machine learning and deep learning to discover insights and automate processes.
• Provide statistical input into study protocols, Case Report Forms, data management plans, and Data Monitoring Committees (DMCs).
• Write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Incorporate Estimand framework while authoring study documents.
• Create specifications and perform analyses such as time-to-event and longitudinal analysis.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers; lead electronic submissions and participate in meetings with regulatory authorities.
• When in Lead Biostatistician role: manage biostatisticians and statistical programmers regarding strategy, deliverables and processes.
• Develop collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
• Generate and apply innovative statistical methodology appropriate to projects and contribute to company visibility.

Principal Biostatistician – Late Phase Development

Clinical Trial Manager I

Principal Biostatistician, FSP

Regional Clinical Study Manager

Senior Biostatistician – FSP

Clinical Trial Manager – FSP