Biostatistician II - Remote

Overview

Provide statistical support for all phases of clinical development, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs.

In Short

• Generate randomization schedules
• Assist with statistical methods review of the clinical study protocol
• Provide and/or verify sample size calculations
• Author statistical analysis plans
• Generate analysis datasets, tables, figures, and listings using SAS
• Assist with quality control for statistical programs
• Provide programming support for regulatory agencies
• Review output across programs for consistency
• Train and mentor new biostatisticians
• Work directly with sponsors and project managers

Requirements

• Master's degree or equivalent in Statistics or Biostatistics with 2+ years of experience
• Experience with SAS
• Knowledge of ICH guidelines and FDA regulations
• Understanding of statistical concepts and techniques
• Excellent organizational and time management skills
• Strong communication and interpersonal skills

Benefits

• Opportunity to work on clinical trials
• Mentorship and training opportunities
• Collaborative work environment
• Engagement with sponsors and project teams