Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology)

Location: United States; remote role

Company

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

What you will do

• Lead statistical activities and provide statistical support for clinical studies, primarily in oncology.
• Serve as lead statistician for assigned studies, overseeing statistical strategy and deliverables.
• Author and review Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports.
• Review and interpret analysis outputs for accuracy, quality, and regulatory compliance.
• Collaborate with Clinical, Programming, Data Management, and Regulatory teams.
• Guide statistical programmers and communicate statistical concepts, results, and risks to technical and non-technical stakeholders.

Requirements

• MS or PhD in Statistics, Biostatistics, or a related field.
• Strong experience in oncology studies.
• Hands-on experience writing Statistical Analysis Plans and Analysis Database Specifications and reviewing analysis results.
• SAS programming skills are required.
• Excellent written and verbal communication skills.
• Experience in a CRO or pharmaceutical/biotechnology environment.

Nice to have

• Experience leading Phase II–III clinical trials.
• Prior interaction with regulatory agencies.
• Experience mentoring junior statisticians or programmers.

Culture & Benefits

• Global, quality-driven one-team culture.
• Professional growth supported by continuous training and close management.
• Work with projects across pharmaceutical, biotechnology, medical device, and consumer health sectors.
• Focus on diversity, inclusion, and employee development.

Hiring process

• CV submission is followed by an application acknowledgement.
• Qualified candidates are invited to a phone interview as the first step.