Overview
Skills
Job Details
Key Responsibilities:
Provide statistical expertise in the design, execution, and analysis of clinical trials
Support protocol development and contribute to study design, including sample size calculations and randomization plans
Author and review Statistical Analysis Plans (SAPs) and statistical sections of protocols and clinical study reports (CSRs)
Generate, validate, and review TLFs (Tables, Listings, and Figures)
Collaborate with data management and clinical teams to ensure data quality and compliance with regulatory requirements
Ensure statistical deliverables align with CDISC standards (SDTM and ADaM)
Participate in regulatory submissions and respond to health authority inquiries
Contribute to cross-functional team meetings and provide biostatistics support throughout the clinical development lifecycle