Principal Biostatistician Consultant - Oncology(Solid Tumors)

Location: United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Principal Biostatistician Consultant  – Oncology (Solid Tumors) to join one of our clients. 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. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-DNP