Associate Director, Biostatistics Consultant – Oncology

🔥 3 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 leadership and strategic guidance for oncology clinical development programs, including Phase I–III clinical trials • Lead the development and review of statistical analysis plans, statistical methodologies, sample size calculations, and randomization strategies • Provide expertise in oncology endpoints, including overall survival, progression-free survival, objective response rate, duration of response, and disease control rate • Oversee statistical analysis of clinical trial data, including time-to-event analyses, Kaplan–Meier estimation, Cox proportional hazards models, and other appropriate methods • Review and oversee clinical study reports, tables, listings, figures, and other statistical deliverables for scientific accuracy and regulatory compliance • Support regulatory submissions and interactions with the FDA, EMA, and other global regulatory agencies • Provide statistical input into clinical study protocols, clinical development plans, and integrated analyses • Collaborate with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, and Regulatory Affairs teams • Serve as a statistical subject matter expert in client meetings, project discussions, and strategic planning sessions • Mentor and provide technical guidance to biostatisticians and other statistical team members • Ensure adherence to regulatory guidelines, industry standards, and internal quality procedures • Contribute to business development activities, including proposal development, feasibility assessments, and client presentations

🎯 Requirements

• PhD in Statistics, Biostatistics, or a closely related quantitative discipline; a Master’s degree with substantial relevant experience may also be considered • Extensive experience in biostatistics within the pharmaceutical, biotechnology, or contract research organization (CRO) industry • Strong experience supporting oncology clinical trials, preferably across multiple phases of clinical development • Demonstrated expertise in survival analysis, time-to-event endpoints, clinical trial design, hypothesis testing, and statistical modeling • Thorough understanding of oncology efficacy endpoints, response assessment criteria such as RECIST, and relevant clinical development considerations • Experience preparing and reviewing SAPs, CSRs, regulatory submission documents, and integrated analyses • Knowledge of FDA, EMA, ICH, and other applicable regulatory guidelines • Strong leadership, communication, problem-solving, and stakeholder management skills • Ability to manage multiple projects, prioritize deliverables, and work effectively in a collaborative, fast-paced environment

🏖️ Benefits

• Continuous training and career development opportunities • Close management and training • Opportunity to work directly for a single sponsor with the security and additional career opportunities of a global CRO • Equal opportunity and commitment to diversity and inclusivity