Principal Biostatistician (Medical Research)

TL;DR

Principal Biostatistician (Medical Research): Leading statistical activities and strategy for clinical trials with an accent on SAP authorship and regulatory compliance. Focus on designing statistical analysis plans, interpreting analysis outputs, and ensuring adherence to FDA/ICH standards.

Location: Remote (United States)

Company

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

What you will do

• Lead statistical strategy and deliverables for clinical studies, primarily within Immunology or other therapeutic areas.
• Author and review key statistical documents, including Statistical Analysis Plans (SAPs) and Analysis Database Specifications (ADS).
• Review and interpret analysis outputs to ensure accuracy, quality, and regulatory compliance.
• Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory.
• Provide guidance and oversight to statistical programmers.
• Communicate statistical concepts, results, and risks to both technical and non-technical stakeholders.

Requirements

• MS or PhD in Statistics, Biostatistics, or a related field.
• Must be based in the United States.
• Strong experience in clinical studies, specifically within Immunology or other therapeutic areas.
• Hands-on experience writing SAPs and Analysis Database Specifications.
• Proficiency in SAS programming.
• Experience working in a CRO 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

• Professional growth within a quality-driven “one-team” culture.
• Commitment to diversity, inclusivity, and equal opportunity employment.
• Strong emphasis on continuous training and personnel development.
• Opportunity to contribute to global health by accelerating innovative drug and device development.

Hiring process

• CV submission and acknowledgement.
• Phone interview for candidates meeting the requirements.