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

Location: Remote within the United States

Company

hirify.global is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Provide statistical expertise and hands-on support for Phase III oncology clinical trials.
• Contribute to study design, statistical analysis, results interpretation, and clinical study deliverables.
• Analyze oncology endpoints including overall survival, progression-free survival, objective response rate, and duration of response.
• Apply censoring, time-to-event, Kaplan-Meier, Cox proportional hazards, and stratified log-rank methods.
• Author and review TFL and ADaM specifications and collaborate with Statistical Programming.
• Support interim analyses, IDMC/DMC activities, output review, discrepancy resolution, and deliverables across multiple concurrent studies.

Requirements

• Advanced degree in Statistics, Biostatistics, or a related quantitative field.
• Direct hands-on experience supporting at least one Phase III oncology clinical trial.
• Strong knowledge of oncology endpoints, censoring rules, and time-to-event analysis.
• Hands-on experience with Kaplan-Meier analysis, Cox proportional hazards models, and stratified log-rank tests.
• Strong SAS programming skills, including independent output review and data and analysis checks.
• Experience with TFL and ADaM specifications, cross-functional collaboration, independent work, and managing multiple clinical trials.

Nice to have

• Experience with FDA or EMA regulatory submissions.
• Experience with IDMC/DMC activities and interim analyses.
• R programming experience.
• Experience in a CRO, pharmaceutical, or biotechnology environment.

Culture & Benefits

• Remote work supporting projects across a diverse client portfolio.
• Professional growth through continuous training and development.
• Collaboration across Biostatistics, Statistical Programming, Data Management, Clinical, and Regulatory functions.
• Work within a quality-driven, one-team culture focused on clinical development.

Hiring process

• Submit a CV and receive an application acknowledgement.
• Selected candidates are invited to a phone interview as the first step.