A clinical-stage biotech is looking to bring on a Director, Biostatistics to lead the statistical strategy for its pivotal Phase 3 program. Fresh off a standout Phase 2 readout with potentially practice-changing data, the company is now scaling its pipeline, with further indications to follow.

This is a highly visible, hands-on individual contributor role, joining a growing biometrics function early in a program with real momentum. Plenty of scope to progress over the coming years.

Responsibilities

• Lead the statistical strategy for a pivotal Phase 3 program, through to submission
• Oversee CRO statistical deliverables, ensuring quality and timelines across trial execution
• Design new trials from scratch as further indications are added, applying innovative designs and quantitative decision-making
• Represent statistics as a voice across the company, communicating directly with executive leadership
• Apply and refine analysis methods that have already been stress-tested on earlier-phase data
• Support regulatory interactions, including IND, NDA/BLA submissions
• Adapt quickly as priorities shift with the program and the competitive landscape
• Contribute to building out in-house biometrics capabilities as the function grows

Experience Required

• PhD in Biostatistics or Statistics; Masters with supplementary experience considered
• Demonstrable experience working directly for a sponsor company
• Late-stage experience, ideally including direct involvement in a regulatory submission
• Track record of overseeing CRO statistical work
• Exceptional communicator, confident presenting to senior leadership and non-statistical audiences
• Self-directed and reliable, comfortable in a lean, fast-moving environment with a high bar for outcomes

Compensation DOE - competitive base salary + bonus, equity and supporting package