[Remote] Associate Director, Biostatistics Consultant – Oncology (Remote)

Note: The job is a remote job and is open to candidates in USA. ClinChoice is recruiting for one of its clients, which is not named, for an Associate Director of Biostatistics Consultant focused on oncology. The role provides statistical leadership across oncology clinical trials and development programs, overseeing study design and analysis, statistical deliverables, and collaboration supporting clinical development and regulatory submissions.

Responsibilities

• 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 (SAPs), statistical methodologies, sample size calculations, and randomization strategies
• Provide expertise in oncology endpoints, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and disease control rate (DCR)
• Oversee the statistical analysis of clinical trial data, including time-to-event analyses, Kaplan–Meier estimation, Cox proportional hazards models, and other appropriate statistical methods
• Review and provide oversight of clinical study reports (CSRs), tables, listings, figures (TLFs), and other statistical deliverables to ensure scientific accuracy and regulatory compliance
• Support regulatory submissions and interactions with health authorities, including 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 applicable regulatory guidelines, industry standards, and internal quality procedures
• Contribute to business development activities, including proposal development, feasibility assessments, and client presentations, as needed

Skills

• 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

• Remote work
• Continuous training

Company Overview

Company H1B Sponsorship