Senior/Principal Statistician (Immunology)

TL;DR

Senior/Principal Statistician (Immunology): Leading and providing statistical support for clinical trials with a strong focus on Immunology therapeutic areas. Focus on overseeing statistical strategy, authoring key statistical documents, and ensuring regulatory compliance.

Location: Remote (United States)

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead and provide statistical support for clinical studies, primarily within Immunology therapeutic areas.
• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables.
• Author and review key statistical documents, including Statistical Analysis Plans (SAPs) and clinical study reports.
• Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance.
• Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory.
• Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders.

Requirements

• MS or PhD in Statistics, Biostatistics, or a related field.
• Strong experience in Immunology clinical studies.
• Proven ability to lead projects and studies independently.
• Hands-on experience writing Statistical Analysis Plans (SAPs) and Analysis Database Specifications.
• SAS programming skills required (hands-on or strong working knowledge).
• Excellent written and verbal communication skills.
• Experience working in a CRO and/or pharmaceutical/biotech environment.

Nice to have

• Experience leading Phase II–III clinical trials.
• Prior interaction with regulatory agencies.
• Experience mentoring junior statisticians or programmers.

Culture & Benefits

• Opportunity to work directly for a single sponsor while having the security of a global CRO.
• Mission-driven culture focused on accelerating the development of innovative drugs and devices.
• Commitment to attracting, developing, and promoting diverse and inclusive talent.
• Continuous training and development for all personnel.
• Evidenced by below industry average employee turnover rates.

Hiring process

• Submit your CV for review.
• Receive an acknowledgement of receipt.
• Successful candidates will be invited for a phone interview as the first step.