Principal Biostatistician Consultant (Oncology)

TL;DR

Principal Biostatistician Consultant (Oncology): Providing statistical leadership for oncology clinical development programs with an accent on SAP development, regulatory submissions, and CDISC standards. Focus on designing statistical methodologies for efficacy and safety analyses and overseeing analysis datasets for Phase I–III trials.

Location: Remote (Must be based in the 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

• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs) for oncology clinical trials.
• Design and review statistical methodologies for efficacy and safety analyses across Phase I–III.
• Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.
• Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.
• Contribute to regulatory submissions (IND, NDA, BLA) and respond to FDA and EMA queries.
• Provide strategic input on study design, endpoint selection, and sample size calculations.

Requirements

• PhD or MS in Statistics, Biostatistics, or a related field.
• 8+ years of industry experience (MS) or 6+ years (PhD) in biostatistics.
• Strong experience in oncology clinical trials, including survival analysis and time-to-event endpoints.
• Proficiency in SAS and/or R.
• Strong knowledge of CDISC standards (SDTM, ADaM).
• Experience supporting regulatory submissions.

Nice to have

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

Culture & Benefits

• Supportive culture with a strong focus on quality and professional development.
• Opportunity to work directly for a single sponsor while maintaining the security of a global CRO.
• Diverse and inclusive work environment with a commitment to equal opportunity.
• Proven stability with below-industry average turnover rates.

Hiring process

• CV submission and initial screening.
• Phone interview as the first step for qualified candidates.