Director of Biostatistics (Biotech)

Location: UK, hybrid with 3 days per week from the office near London Bridge

Company

hirify.global is building a technology-first biopharma platform that in-licenses clinical-stage therapeutic assets and develops them through integrated clinical trial infrastructure.

What you will do

• Set statistical strategy across the growing clinical asset portfolio and lead biostatistics, statistical programming, and medical writing functions.
• Personally lead statistical work on active and incoming programmes from protocol development through database lock and clinical study report.
• Author and review statistical analysis plans, sample size and power calculations, randomisation schemes, interim analyses, and DSMB packages.
• Represent biostatistics with health authorities, prepare responses and briefing documents, and author or review statistical sections of IND and NDA submissions.
• Evaluate clinical data packages for in-licensing, including trial design, endpoint selection, signal strength, and risks affecting development strategy or deal terms.
• Oversee CDISC-compliant statistical programming and medical writing deliverables, assess CRO/FSP partnerships, and identify useful AI/ML applications.

Requirements

• PhD in statistics or biostatistics with 10+ years of relevant pharma or biotech experience, or MS with 15+ years, including lead statistician experience across multiple Phase I/II programmes.
• Experience interacting with health authorities on at least one programme, including formal meetings or written correspondence; FDA experience is preferred and EMA experience is considered.
• Experience with adaptive trial design, programme- or portfolio-level statistical strategy, CDISC standards, regulatory submissions, and current drug development practices.
• Excellent programming skills with the ability to independently generate analysis output; fluency in R and/or SAS is preferred.
• Strong written and verbal communication skills and the ability to operate as both a leader and hands-on contributor.

Nice to have

• Phase III and clinical study report experience.
• Experience evaluating external clinical data during due diligence, licensing, or M&A activity.
• Experience applying AI/ML tools to statistical workflows.

Culture & Benefits

• Hybrid working with an office near London Bridge.
• 30 days of annual leave in addition to Bank Holidays.
• Stock options, health and wellness benefits, and a £60 monthly wellness allowance.
• Enhanced parental leave and a £1,000 annual learning and development allowance.
• Company and team events, gym and retail discounts, cycle-to-work options, and catered UK office meals.

Hiring process

• Initial 30-minute conversation with the Senior Talent Partner.
• 30-minute conversation with the VP of Data.
• 60-minute technical interview with biostatistics experts, followed by a 30-minute values interview with two Senior Leadership Team members.