Principal Biostatistician Consultant (Respiratory & Immunology)

TL;DR

Principal Biostatistician Consultant (Respiratory & Immunology): Providing statistical oversight and leadership for clinical trials within the respiratory and immunology therapeutic area with an accent on study design, protocol development, and regulatory compliance. Focus on ensuring data integrity, mentoring junior staff, and delivering high-quality statistical analysis plans for client-facing projects.

Location: Must be based in the United States

Company

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

What you will do

• Lead protocol development, including study design, sample size calculation, and randomization.
• Provide statistical oversight to ensure quality and consistency across clinical studies.
• Develop and execute statistical analysis plans and ensure the accuracy of reports and regulatory submissions.
• Validate analysis strategies and explore alternative methodologies as required.
• Mentor peers and coordinate statistical activities across multiple projects.
• Communicate effectively with internal teams and client counterparts to ensure project delivery.

Requirements

• Must be based in the United States
• MS or PhD in Statistics, Biostatistics, or a related field.
• PhD with 2-4 years or MS with 5-7 years of relevant industry experience.
• Proven experience in Respiratory & Immunology clinical trials, specifically Asthma studies.
• Strong proficiency in SAS.
• Demonstrated understanding of FDA regulations and the drug development process.

Culture & Benefits

• Opportunity to work with a global CRO while maintaining a dedicated client-facing role.
• Strong focus on professional development and continuous training.
• Supportive culture with below-industry-average turnover rates.
• Commitment to diversity, inclusivity, and equal opportunity employment.

Hiring process

• Initial CV review and screening.
• Phone interview as the first step in the evaluation process.