Senior/Principal Statistician Consultant – Phase III Oncology

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

💼 Consultant

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 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 deliverables • Apply censoring and time-to-event analyses • Apply and interpret Kaplan-Meier analysis, Cox Proportional Hazards models, and stratified log-rank tests • Author, review, and provide input into TFL and ADaM specifications with Statistical Programming • Review statistical programming outputs, identify discrepancies, and collaborate with programmers to resolve issues • Use SAS to review outputs and perform data and analysis checks • Manage deliverables across multiple concurrent clinical studies • Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams • Support interim analyses and IDMC/DMC activities, including preparation and review of DMC outputs

🎯 Requirements

• 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 • Experience authoring or reviewing TFL and ADaM specifications • Ability to identify and resolve discrepancies in analysis outputs • Ability to work independently with minimal supervision • Ability to manage deliverables across multiple concurrent clinical trials • Excellent written and verbal communication skills • Experience supporting FDA and/or EMA regulatory submissions preferred • Experience with IDMC/DMC activities and interim analyses preferred • Experience with R programming is a plus • Experience working in a CRO, pharmaceutical, or biotechnology environment preferred

🏖️ Benefits

• Professional growth opportunities • Continuous training and development • Equal opportunity and diversity-focused workplace