Associate Director, Biostatistics Consultant (Oncology)

Location: Remote in the European Union, with a focus on Western EU

Company

hirify.global is a global full-service CRO 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.
• Design clinical trials, including superiority, non-inferiority, equivalence-based, adaptive, seamless Phase II/III, group sequential, basket, and umbrella studies.
• Define and validate primary and secondary endpoints, including overall survival, biomarker response rates, and quality-of-life measures.
• Perform sample size, power, subgroup-powering, simulation, and statistical methodology work.
• Establish proof-of-concept criteria, go/no-go decision gates, and futility stopping rules.
• Support commercial and portfolio teams with probability-of-technical-success assessments, risk models, and pipeline prioritization.

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.
• 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 preparation and review of data packages, trial designs, endpoints, and statistical analysis plans.
• Experience addressing regulatory concerns involving missing data, multiplicity adjustments, and bias.
• Excellent communication and leadership skills, with the ability to influence senior cross-functional stakeholders.

Culture & Benefits

• Work directly for a single sponsor with the security and career opportunities of a global CRO.
• Access to continuous training and development focused on internal and client processes.
• Work within a diverse and inclusive equal opportunity environment.
• Join an organization with more than 4,000 professionals across over 20 countries.

Hiring process

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