Principal Statistician Consultant (Respiratory & Immunology)

TL;DR

Principal Statistician Consultant (Biostatistics/SAS): Leading protocol development and statistical analysis for respiratory and immunology clinical trials with an accent on study design, sample size calculation, and FDA regulatory compliance. Focus on providing statistical oversight for asthma studies, mentoring junior statisticians, and ensuring high-quality data consistency for regulatory submissions.

Location: Remote (Must be based in the EU or UK)

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

• Develop study protocols, including study design, sample size calculations, randomization, and statistical analysis plans (SAP).
• Provide statistical oversight to ensure data quality, consistency, and adherence to project requirements.
• Lead the creation and validation of statistical tables, figures, and data listings for reports.
• Review scientific reasoning and correct flaws in statistical interpretation and report text.
• Mentor peer statisticians and coordinate assignments to ensure high-quality, timely project delivery.
• Interact with regulatory agencies, specifically the FDA, regarding clinical trial data.

Requirements

• MS in Statistics/Biostatistics (5-7 years experience) or PhD (2-4 years experience).
• Must be based in the European Union or United Kingdom.
• Strong proficiency in SAS and R programming.
• Experience in Respiratory & Immunology therapeutic areas, specifically with Asthma studies.
• Deep understanding of the drug development process and FDA regulations.
• Proven experience working within a CRO or pharmaceutical industry environment.

Culture & Benefits

• Supportive culture with a strong emphasis on professional development and continuous training.
• Opportunity to work directly for a single sponsor while maintaining the security of a global CRO.
• Inclusive work environment that celebrates diversity across gender, race, and ethnicity.
• High organizational stability with below-industry average turnover rates.

Hiring process

• Initial CV screening.
• Phone interview for candidates meeting the core requirements.