Senior Director of Biostatistics

Location: Remote, US

Company

hirify.global is building a technology-first clinical trial infrastructure and developing clinical-stage therapeutic assets through an integrated biopharma platform.

What you will do

• Set statistical strategy across the clinical portfolio and lead the biostatistics, statistical programming, and medical writing functions.
• Act as lead statistician on active and incoming programmes from protocol development through database lock and clinical study reports.
• Author and review statistical analysis plans, sample size and power calculations, randomisation schemes, interim analyses, and DSMB packages.
• Represent statistics in regulatory meetings, briefing documents, health authority responses, and IND and NDA submissions.
• Evaluate clinical data packages during due diligence for in-licensing targets, assessing trial design, endpoints, signal strength, and development risks.
• Oversee programming and medical writing deliverables, CRO/FSP partnerships, and the use of AI and machine learning in statistical workflows.

Requirements

• PhD in statistics or biostatistics with 10+ years of relevant pharma or biotech experience, or MS with 15+ years.
• Lead statistician experience across multiple early-phase programmes, including at least one programme through a clinical study report.
• Experience interacting with health authorities on multiple programmes and required experience with adaptive trial design.
• Strong knowledge of CDISC standards, regulatory submission requirements, and drug development practices.
• Excellent programming skills with the ability to independently generate analysis outputs; fluency in R and/or SAS is preferred.
• Experience with statistical strategy, due diligence, team leadership, hiring, and function building.

Nice to have

• Experience with FDA interactions; EMA experience is also considered.
• Experience evaluating external clinical data through licensing or M&A activity.
• Familiarity with applying AI and machine learning tools to statistical workflows.

Culture & Benefits

• 27 days of annual leave plus 11 national holidays.
• Health insurance coverage through PEO Trinet and a monthly wellness allowance.
• Enhanced parental leave, including 16 weeks of full pay for primary caregivers and 6 weeks for secondary caregivers.
• $2,000 annual learning and development allowance.
• Remote-team lunch vouchers, company and team events, gym and retail discounts, and charity opportunities.
• Competitive salary and stock options.

Hiring process

• Initial conversation with the Senior Talent Partner.
• Conversation with the VP of Data, followed by a technical interview with biostatistics experts.
• Values interview with two Senior Leadership Team members.