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

Key Responsibilities

• 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 deliverables.
• Demonstrate a strong understanding of key oncology endpoints, including:
  • Overall Survival (OS)
  • Progression-Free Survival (PFS)
  • Objective Response Rate (ORR)
  • Duration of Response (DoR)
• Apply appropriate methods for censoring and time-to-event analyses.
• Apply and interpret statistical methodologies including:
  • Kaplan-Meier analysis
  • Cox Proportional Hazards models
  • Stratified log-rank tests
• Author, review, and provide input into TFL and ADaM specifications in close collaboration with Statistical Programming.
• Review statistical programming outputs, identify discrepancies, and work collaboratively with programmers to resolve issues.
• Use SAS to independently review outputs and perform data and analysis checks.
• Manage deliverables across multiple concurrent clinical studies, ensuring timelines and quality expectations are met.
• Work independently with minimal supervision and quickly become familiar with study requirements, datasets, and programming outputs.
• Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams as required.
• Support interim analyses and Independent Data Monitoring Committee (IDMC/DMC) activities, including preparation and review of DMC outputs.

Required Qualifications

• Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative field.
• 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 perform independent checks.
• Experience authoring or reviewing TFL and ADaM specifications and collaborating closely with Statistical Programming.
• Strong problem-solving skills with the ability to identify and resolve discrepancies in analysis outputs.
• Ability to work independently, quickly onboard to new studies, and operate effectively with minimal supervision.
• Demonstrated ability to manage deliverables across multiple concurrent clinical trials while maintaining quality and timelines.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience supporting FDA and/or EMA regulatory submissions.
• Experience with IDMC/DMC activities and interim analyses, including preparation and review of DMC outputs.
• Experience with R programming is a plus.
• Experience working in a CRO, pharmaceutical, or biotechnology environment.

Key Competencies

• Phase III Oncology
• Time-to-Event Analysis
• Survival Analysis
• SAS
• TFL and ADaM Specifications
• Statistical Programming Collaboration
• Clinical Trial Analysis
• Regulatory Submissions
• IDMC/DMC Support
• Multi-Study Project Management
• Independent/Self-Directed Work