Principal Biostatistician Consultant (Oncology)

TL;DR

Principal Biostatistician Consultant (Oncology): Providing statistical leadership for oncology clinical development programs, supporting Phase I–III clinical trials, and contributing to regulatory submissions. Focus on designing and reviewing statistical methodologies, overseeing analysis datasets in compliance with CDISC standards, and supporting interim analyses.

Location: Remote in US

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

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).
• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
• Design and review statistical methodologies for efficacy and safety analyses.
• Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.
• Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries.
• Provide strategic input on study design, endpoint selection, and sample size calculations.

Requirements

• PhD or MS in Statistics, Biostatistics, or related field.
• 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.
• Strong experience in oncology clinical trials.
• Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.
• Proficiency in SAS and/or R.
• Strong knowledge of CDISC standards (SDTM, ADaM).

Nice to have

• Experience with adaptive designs and Bayesian methods.
• Prior experience interacting with regulatory agencies.
• Experience in immuno-oncology or hematology oncology.

Culture & Benefits

• Opportunity to work directly for a single sponsor within a global CRO framework.
• Strong focus on quality, professional development, and supportive culture.
• Continuous training to develop and maintain highly-qualified personnel.
• Globally distributed team with over 4,000 professionals in more than 20 countries.
• Commitment to diversity and inclusivity, with an equal opportunity employer policy.

Hiring process

• Submit CV.
• Successful candidates will be invited for a phone interview.