Associate Director, Biostatistics Consultant – Oncology (Remote in Western EU)

ClinChoice is seeking an experienced Associate Director, Biostatistics Consultant to join our team and provide strategic statistical leadership for oncology drug development programs. This role offers the unique opportunity to work directly with a single sponsor while benefiting from the global resources and career development support of a leading CRO.

Key responsibilities

• Provide strategic statistical leadership across clinical development programs, collaborating with regulatory, medical, and commercial teams.
• Define and validate primary and secondary endpoints to ensure they are clinically meaningful and statistically robust.
• Design innovative clinical trials, including adaptive, seamless Phase II/III, and biomarker-driven designs.
• Establish quantitative thresholds for decision-making, including proof-of-concept criteria and futility stopping rules.
• Lead regulatory strategy and health authority negotiations, including the preparation and defense of statistical analysis plans and data packages.
• Quantify uncertainty and probability of technical success using historical benchmark data and simulation models to support portfolio prioritization.

Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline.
• Significant experience in pharmaceutical, biotechnology, or CRO environments with a strong focus on oncology.
• Demonstrated expertise in strategic drug development and advanced clinical trial design.
• Comprehensive knowledge of oncology endpoints, sample size calculations, and statistical methodology.
• Proven experience supporting regulatory submissions and interacting with health authorities.
• Excellent communication and leadership skills with the ability to influence senior cross-functional stakeholders.

What we offer

• The opportunity to work in a global, full-service CRO environment with over 28 years of industry experience.
• A supportive culture focused on continuous training, professional development, and high-quality delivery.
• A diverse and inclusive workplace that values talent and promotes equal opportunity.
• A fully remote position allowing for professional growth within a global team of over 4,000 experts.