Principal Biostatistician Consultant - Oncology (Solid Tumors)

Position Overview

We are seeking an experienced Principal Biostatistician with strong expertise in oncology clinical development, particularly solid tumor studies, to provide statistical leadership and strategic support across clinical trials. The ideal candidate will have extensive experience in the design, execution, analysis, and reporting of oncology clinical trials, along with a strong understanding of oncology endpoints, regulatory requirements, and clinical development strategies. This role requires close collaboration with Clinical Development, Data Management, Statistical Programming, Regulatory Affairs, and other cross-functional stakeholders to ensure high-quality statistical deliverables throughout the clinical development lifecycle.

Key Responsibilities

• Provide statistical leadership and strategic input into the design and execution of clinical trials in oncology, particularly solid tumor indications.
• Lead and contribute to the development of clinical study protocols, statistical analysis plans (SAPs), and other statistical documents.
• Provide statistical expertise in clinical trial design, including Phase I, II, and III studies.
• Develop and review statistical methodologies for oncology endpoints, including Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR), and Disease Control Rate (DCR).
• Apply appropriate statistical methodologies for time-to-event analyses, including Kaplan-Meier estimates, Cox proportional hazards models, and log-rank tests.
• Provide statistical input on interim analyses, sample size calculations, power calculations, and adaptive trial designs, where applicable.
• Oversee statistical analyses and ensure the accuracy, consistency, and quality of statistical outputs, including TFLs.
• Collaborate with statistical programmers to ensure the implementation of statistical analysis plans and delivery of high-quality ADaM datasets and TFLs.
• Interpret clinical trial results and contribute to clinical study reports (CSRs), regulatory submissions, and scientific publications.
• Provide statistical guidance and mentorship to junior statisticians and cross-functional team members.
• Ensure compliance with applicable regulatory guidelines, ICH-GCP, and industry standards.

Required Qualifications and Experience

• PhD or Master's degree in Biostatistics, Statistics, or a related quantitative discipline.
• Extensive experience in clinical development within the pharmaceutical or biotechnology industry.
• Strong experience as a Biostatistician supporting oncology clinical trials, particularly solid tumor studies.
• Significant experience in Phase I, II, and III clinical trial design, analysis, and reporting.
• Strong knowledge of oncology endpoints, including OS, PFS, ORR, DoR, and DCR.
• Hands-on expertise in survival analysis, including Kaplan-Meier methodology, Cox regression, and log-rank testing.
• Experience developing protocols, SAPs, and statistical sections of clinical study reports.
• Strong knowledge of CDISC standards, including CDASH and ADaM, and regulatory submission requirements.
• Proficiency in SAS and/or R for statistical analysis.
• Experience working with cross-functional clinical development teams and providing statistical leadership.
• Excellent communication, presentation, and problem-solving skills.