Associate Director, Biostatistics Consultant – Oncology

ClinChoice

. Provide statistical leadership and strategic guidance for oncology clinical development programs, including Phase I–III clinical trials .

Posted 10/26/2026contractRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical methodologies and oncology clinical trial design, with a strong focus on survival analysis and regulatory compliance. Proven ability to lead statistical teams and collaborate effectively across clinical development functions.

Highest-signal resume keywords

PhD In Statistics Or BiostatisticsExtensive Experience In BiostatisticsOncology Clinical Trials ExpertiseSurvival Analysis And Time-To-Event EndpointsKnowledge Of FDA And EMA Regulatory Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis Plans (SAPs)Sample Size CalculationsKaplan–Meier EstimationCox Proportional Hazards ModelsClinical Trial DesignHypothesis TestingStatistical ModelingOncology Efficacy EndpointsResponse Assessment Criteria (RECIST)Regulatory Submission Documents

Soft Skills

LeadershipCommunicationProblem-SolvingStakeholder ManagementCollaboration

Industry Keywords

Pharmaceutical IndustryBiotechnologyContract Research Organization (CRO)Clinical DevelopmentRegulatory ComplianceClinical OperationsData ManagementStatistical ProgrammingMedical WritingBusiness Development

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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