Principal Biostatistician Consultant (Oncology)

TL;DR

Principal Biostatistician Consultant (Oncology): Developing protocols, sample size calculations, and statistical analysis plans for late-phase oncology studies with an accent on FDA regulatory compliance and data validity. Focus on providing statistical oversight, mentoring junior statisticians, and ensuring the accuracy of clinical trial reports.

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

• Develop study protocols, including design, sample size calculation, and randomization.
• Create and oversee statistical analysis plans (SAP) for assigned studies.
• Ensure the accuracy, completeness, and consistency of data used for statistical analyses.
• Review and validate statistical tables, figures, and data listings to ensure report consistency.
• Mentor peers on statistical methodology and provide training to less experienced statisticians.
• Coordinate and review the work of statisticians across multiple projects to ensure high-quality, timely delivery.

Requirements

• MS (5-7 years exp) or PhD (2-4 years exp) in Statistics, Biostatistics, or a related field.
• Oncology TA experience required.
• Strong proficiency in SAS.
• Demonstrated understanding of drug development processes and FDA regulations.
• Experience in Pharmaceutical or CRO industries working with clinical trials and regulatory agencies.
• Strong oral and written communication skills for effective client interaction.

Culture & Benefits

• Opportunity to work directly for a single sponsor while benefiting from the security of a global CRO.
• Supportive culture with a strong focus on quality and professional development.
• Continuous training and management to maintain high-level expertise and competence.
• Inclusive and diverse work environment that celebrates different backgrounds.

Hiring process

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