Principal Biostatistician (Medtech)

TL;DR

Principal Biostatistician (Medtech): Providing statistical leadership and support for all phases of clinical development with an accent on study design, regulatory strategy, and complex program oversight. Focus on authoring statistical analysis plans, mentoring team members, and serving as a subject matter expert for advanced methodologies like Bayesian adaptive designs and survival analysis.

Location: Remote (Canada)

Salary: $149,000–$246,000

Company

hirify.global is a specialized services organization providing integrated research and development solutions to the life sciences industry.

What you will do

• Consult with clients on clinical trial study design and regulatory strategy.
• Develop and review statistical methods and sample size calculations for protocols.
• Author and review complex statistical analysis plans.
• Provide statistical analysis and reporting to Data Monitoring Committees.
• Mentor and train other biostatisticians within the team.
• Represent the company in bid defense meetings for complex programs.

Requirements

• Master's or PhD in Statistics, Biostatistics, or a related field.
• 10+ years of experience for Principal level or 12+ years for Senior Principal level.
• Broad experience with regulatory submissions and industry standards like ICH, CDISC, and FDA guidelines.
• Extensive experience with SAS programming.
• Must be based in Canada.
• Strong communication and interpersonal skills for client consulting.

Nice to have

• Experience with oncology and rare disease clinical trials.
• Expertise in Bayesian adaptive study design or survival analysis.
• Previous experience working with Data Monitoring Committees.

Culture & Benefits

• Comprehensive health, life, and disability insurance.
• Retirement savings benefits.
• Paid time off for vacation and sick leave.
• Parental leave support.
• Discretionary annual bonus eligibility.