ClinChoice Benefits Overview

Lead data management for clinical trials including database setup, eCRF specification, validation/edit checks, testing, data review/reconciliation, SAE reconciliation, database lock/unlock, vendor data transfers, training, and DM documentation to meet timelines and quality standards.

Leads and supports statistical programming deliverables for oncology clinical studies, implementing protocol and clinical development requirements. Independently programs high-quality outputs, develops specifications, oversees documentation, ensures standards and automation compliance, supports team activities, manages risks, and collaborates with statisticians, lead programmers, data managers, and study leaders. The role also contributes to programming best practices and requires strong knowledge of clinical research, drug development, ICH, Good Clinical Practices, and regulatory requirements.

Leads statistical activities for oncology clinical trials, serving as lead statistician for study strategy and deliverables. Authors and reviews Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports. Interprets analysis outputs, ensures regulatory compliance, collaborates with clinical, programming, data management, and regulatory teams, and guides statistical programmers. Communicates statistical results and risks to technical and non-technical stakeholders.