Senior/Principal Statistician Consultant - Phase III Oncology (Remote)

📋 Description

• Provide statistical expertise and hands-on support for Phase III oncology clinical trials
• Contribute to study design, statistical analysis, interpretation of results, and clinical study
• Demonstrate a strong understanding of key oncology endpoints, including OS, PFS, ORR, and DoR
• Apply appropriate methods for censoring and time-to-event analyses
• Apply and interpret statistical methodologies including Kaplan-Meier analysis, Cox Proportional
• Author, review, and provide input into TFL and ADaM specifications in close collaboration with

🎯 Requirements

• Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative
• Direct hands-on experience supporting at least one Phase III oncology clinical trial
• Strong understanding of oncology clinical trial endpoints, including OS, PFS, ORR, and DoR
• Strong knowledge of censoring rules and time-to-event analysis
• Hands-on experience with Kaplan-Meier, Cox Proportional Hazards, and stratified log-rank methods
• Strong SAS programming skills with the ability to review statistical programming outputs and

🎁 Benefits

• Preferred qualifications: Experience supporting FDA and/or EMA regulatory submissions
• Preferred qualifications: Experience with IDMC/DMC activities and interim analyses, including
• Preferred qualifications: Experience with R programming is a plus
• Preferred qualifications: Experience working in a CRO, pharmaceutical, or biotechnology environment