Principal Statistician (Clinical Research)

Location: Remote, United States

Company

hirify.global is a global contract research organization supporting clinical trials and the development of new medicines.

What you will do

• Lead statistical activities for global clinical trials and act as a statistical communication point for project teams, clients, vendors, and internal stakeholders.
• Conduct interim, final, DSMB/DMC, pharmacokinetic, and other advanced clinical trial analyses.
• Develop and review protocols, statistical analysis plans, ADaM dataset specifications, and other study documents.
• Review tables, figures, listings, analysis datasets, and statistical deliverables.
• Lead project-level teams of SAS programmers and statisticians, and provide training and induction sessions.
• Support audits, quality system documentation, data-management discussions, bid defenses, and study kick-off meetings.

Requirements

• MSc in Statistics or an equivalent qualification.
• Expert knowledge of statistical principles, methods, standards, SAS programming, and CDISC ADaM.
• Expertise in adaptive designs, sample size calculation, and relevant FDA, EMA, and ICH regulations and guidelines.
• Ability to apply advanced statistical techniques, interpret complex statistical information, and develop analysis strategies for clinical research.
• Strong presentation, communication, consulting, and team leadership skills.
• Ability to work remotely from the United States.

Culture & Benefits

• Work on clinical research programs that support the development of new medicines.
• Collaborate with international teams of statisticians, programmers, data managers, clients, and vendors.
• Participate in a structured recruitment process with support throughout each stage.
• Contribute to quality systems, departmental training, and continuous improvement.

Hiring process

• Follow a straightforward recruitment process with support at every step.