Principal Biostatistician (Clinical Research)

Location: Remote in the United Kingdom; listed location: London, England, United Kingdom

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission services.

What you will do

• Lead complex clinical research projects, programs, and regulatory submissions while managing client meetings and collaborating with regulatory teams, project managers, and sponsors.
• Develop and review statistical analysis plans, interim statistical analysis plans, statistical methods, and clinical study report sections independently.
• Review or develop ADaM specifications and collaborate with programmers and junior statisticians to resolve comments.
• Provide statistical consulting on study design, statistical methods, and sample size calculations across a range of clinical trial scenarios.
• Create randomization and kit schedules and support Data Safety Monitoring Boards as an unblinded statistician.
• Guide colleagues in biostatistical techniques, contribute to external presentations and publications, and stay current with regulatory and industry practices.

Requirements

• Master’s degree in Biostatistics, Statistics, or a related discipline, or equivalent relevant experience; PhD preferred.
• At least 7 years of experience in biostatistics, statistics, or a similar field.
• Experience with regulatory submissions, including ISS and ISE.
• Advanced knowledge of drug development, scientific principles, clinical trial data, and pharmaceutical development.
• Familiarity with 21 CFR Part 11, FDA, GCP, and current ISO 9001 and ISO 27001 standards.
• Strong communication, organization, problem-solving, collaboration, and Microsoft Office skills.

Culture & Benefits

• Collaborative and inclusive working environment.
• Supportive team focused on innovative clinical research.
• Great Place to Work certified organization.
• Opportunity to contribute to work supporting pharmaceutical, biotech, and medical device industries.