Senior Statistician (Clinical Trials)

Location: Durham, NC, USA

Company

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

What you will do

• Conduct interim, final, DSMB/DMC, pharmacokinetic, and other statistical analyses for clinical trials.
• Develop and review study protocols, statistical analysis plans, ADaM dataset specifications, and project documentation.
• Review tables, figures, listings, analysis datasets, and other statistical deliverables.
• Lead project-level teams of SAS programmers and statisticians while coordinating with clients, vendors, data management, and international teams.
• Support audits, audit follow-up activities, bid defenses, kick-off meetings, and statistical quality systems.
• Deliver induction and project-specific training for statisticians and SAS programmers.

Requirements

• MSc in Statistics or an equivalent qualification.
• Expert knowledge of statistical principles, methods, and standards used in clinical research.
• Expert knowledge of SAS programming and the CDISC ADaM standard.
• Strong understanding of adaptive designs, sample size calculation, and FDA, EMA, and ICH regulations.
• Ability to apply advanced statistical techniques, interpret complex data, and develop analysis strategies for clinical studies.
• Strong presentation, communication, consulting, and collaboration skills.

Culture & Benefits

• Work alongside international teams of statisticians, programmers, and data managers.
• Contribute to medical science and the development of new medicines.
• Participate in a straightforward recruitment process with support throughout each step.
• Join a global organization founded in 1995 with more than 3,000 employees.