Director of Biostatistics

Location: US; remote

Company

hirify.global is building a technology-first clinical trial infrastructure and developing in-licensed clinical-stage therapeutic assets through its Lindus Therapeutics initiative.

What you will do

• Set statistical strategy across a growing 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 interactions with health authorities and contribute to IND, NDA, and other regulatory submissions.
• Evaluate clinical data packages during due diligence for in-licensing opportunities, identifying statistical risks that may affect development strategy or deal terms.
• Oversee CDISC-compliant programming deliverables, medical writing output, external CRO/FSP partnerships, and the use of AI/ML in statistical workflows.

Requirements

• PhD in statistics or biostatistics with 10+ years of relevant pharma/biotech experience, or MS with 15+ years.
• Lead statistician experience across multiple Phase I/II programmes, including adaptive trial design experience.
• Direct interaction with health authorities on at least one programme; FDA experience is preferred and EMA experience is also considered.
• Experience setting statistical strategy at programme or portfolio level, with strong knowledge of CDISC standards, regulatory submissions, and drug development.
• Ability to independently generate analysis output and fluency in R and/or SAS.
• Strong written and verbal communication skills, with 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 through due diligence, licensing, or M&A.
• Experience applying AI/ML tools to statistical workflows.

Culture & Benefits

• Competitive salary and meaningful stock options.
• 27 days of annual leave plus 11 national holidays.
• Health insurance coverage through Trinet, a $40 monthly wellness allowance, and gym and retail discounts.
• Enhanced parental leave: 16 weeks for primary caregivers and 6 weeks for secondary caregivers.
• $2,000 annual learning and development allowance, remote-team lunch vouchers, and regular company and team events.

Hiring process

• Initial 30-minute conversation with the Senior Talent Partner.
• 30-minute conversation with the VP of Data.
• Technical interview with biostatistics experts, followed by a 30-minute values interview with two senior leadership team members.