Associate Director, Biostatistics Consultant – Oncology

Location: Remote in the United Kingdom; Outside IR35 contract

Company

hirify.global is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Provide strategic statistical leadership across oncology drug-development programs and clinical-trial strategy.
• Select superiority, non-inferiority, or equivalence trial types according to regulatory and payer evidence needs.
• Define and validate clinically meaningful, measurable, and statistically robust primary and secondary endpoints.
• Design adaptive trials, including seamless Phase II/III, group sequential, basket, umbrella, and biomarker-driven designs.
• Perform sample-size, power, subgroup-powering, and simulation analyses while balancing statistical risk, patient exposure, and resources.
• Establish go/no-go criteria, proof-of-concept thresholds, futility stopping rules, regulatory strategies, and portfolio decision support.

Requirements

• Master’s or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline.
• Significant experience in pharmaceutical, biotechnology, or CRO environments with strong oncology experience.
• Demonstrated experience in strategic drug development and clinical-trial design beyond traditional study-level responsibilities.
• Strong knowledge of oncology endpoints, adaptive designs, sample-size and power calculations, simulations, and statistical methodology.
• Experience supporting regulatory submissions and interacting with health authorities, including preparing or reviewing data packages and attending regulatory meetings.
• Experience addressing statistical and regulatory risks involving missing data, multiplicity adjustments, bias, trial design, endpoints, and statistical analysis plans.
• Experience using historical benchmarks and simulation models to estimate probability of technical success across development phases and support pipeline prioritization.
• Excellent communication and leadership skills, with the ability to influence senior cross-functional stakeholders.

Culture & Benefits

• Work directly for a single sponsor while receiving career opportunities associated with a global CRO.
• Access to continuous training focused on maintaining professional competence and expertise.
• Work within an organization operating across more than 20 countries and serving pharmaceutical, biotechnology, medical device, and consumer health clients.
• Inclusive and diverse workplace with equal-opportunity employment principles.

Hiring process

• Submit a CV and receive an acknowledgement of receipt.
• Qualified applicants are invited to a phone interview as the first step.