Senior Director, Biometrics (Biotech)

Location: Cambridge, Massachusetts, United States

Base salary: $263,000–$292,000 USD per year, plus annual short-term and long-term incentive awards.

Company

hirify.global is a biotechnology company developing gene editing therapies through its proprietary Prime Editing platform, with clinical programs in hematology, immunology and oncology, liver, and lung diseases.

What you will do

• Lead biometrics strategy across biostatistics, clinical data management, and vendor-delivered statistical programming.
• Provide statistical leadership for clinical trial design, protocol development, dose-escalation strategy, endpoint selection, estimands, interim analyses, and submission planning.
• Review and approve statistical analysis plans, interim and final analyses, Clinical Study Report statistical sections, and supporting SRC and DMC outputs.
• Support IND/CTA submissions, health authority briefing packages, regulatory interactions, and responses to questions on study design and analyses.
• Provide strategic oversight and line management for Clinical Data Management, including CRF design, database builds, data cleaning, validation, and database lock.
• Lead CRO and biometrics vendor selection, governance, performance oversight, budgets, inspection readiness, and issue resolution.

Requirements

• Advanced degree in Statistics, Biostatistics, Mathematics, or a related quantitative field.
• At least 10 years of biometrics experience in biotechnology or pharmaceutical development.
• Experience supporting clinical development programs from early phase through later-stage development, including regulatory submissions.
• Experience serving as lead statistician for clinical studies and regulatory submissions.
• Strong knowledge of clinical trial design, statistical principles, data management, rare disease, and gene or cell therapies.
• Experience leading biometrics through CRO or vendor models, with familiarity with FDA, EMA, ICH, and CDISC/SDTM/ADaM expectations.

Nice to have

• Experience leading or managing Clinical Data Management.
• Experience with early-phase first-in-human studies and later-stage programs.

Culture & Benefits

• Comprehensive health, financial, and wellness benefits, including medical, dental, vision, and life insurance.
• 401(k) match and equity programs.
• Generous paid time off, wellness days, and company-wide recharge breaks.
• Work in a lean, fast-moving biotechnology environment focused on patient impact.