Principal Biostatistician (Biotech)

TL;DR

Principal Biostatistician (Biotech): Leading statistical strategy and clinical trial analysis for genetic medicine programs with an accent on regulatory compliance, CDISC standards, and innovative methodology. Focus on overseeing outsourced CRO activities, driving statistical rigor in drug development, and collaborating across cross-functional teams to advance clinical-stage programs.

Location: US-based remote position, with preference for candidates in New England. Requires quarterly travel to Boston, MA.

Salary: $203,000–$247,000

Company

hirify.global is a clinical-stage biopharmaceutical company developing a new class of genetic medicines to treat neuromuscular and inherited retinal diseases.

What you will do

• Develop statistical strategies for drug programs, including protocol design, SAPs, and regulatory documentation.
• Oversee external CRO activities, ensuring high-quality and timely delivery of biostatistics deliverables.
• Review randomization procedures, Case Report Forms, and data management plans.
• Provide statistical input for CSRs, scientific presentations, and manuscripts.
• Develop innovative statistical tools and methodologies through literature review.
• Participate in cross-functional initiatives regarding standards, infrastructure, and processes.

Requirements

• Ph.D. in Statistics or related field with 6+ years of experience in the biotech/pharmaceutical industry.
• Must be based in the US.
• Strong statistical programming skills in R, SAS, and Python.
• Deep understanding of regulatory guidelines, CDISC, SDTM, and ADaM specifications.
• Proven experience in vendor management.
• Excellent communication skills and a proactive, results-oriented mindset.

Nice to have

• Experience in Neuromuscular or Ophthalmology therapeutic areas.
• Knowledge of machine learning and artificial intelligence applications in analytics.

Culture & Benefits

• Comprehensive health, dental, and vision coverage.
• 401(k) plan with company match.
• Paid, gender-inclusive parental leave.
• Education reimbursement and commuting benefits.
• Discretionary time off and a mission-driven, collaborative team environment.