Senior Principal Statistician, Biostatistics

Location: Remote/Home-Based in Dublin, Ireland; Cambridge, UK; or London, UK

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a focus on oncology, neuroscience, sleep disorders, and epilepsy.

What you will do

• Lead statistical activities for individual studies, related studies, integrated summaries, and regulatory filings across Phase I–IV clinical trials.
• Contribute to clinical study design, endpoints, protocols, statistical analysis plans, analyses, validation, and clinical data displays.
• Develop statistical programs in SAS and R to simulate trial designs, analyze data, and verify programming outputs.
• Collaborate with clinical development, pharmacology, pharmacovigilance, regulatory affairs, medical writing, data management, and clinical operations.
• Prepare for regulatory agency meetings and respond to statistical questions.
• Manage and validate statistical deliverables from external CROs and programming vendors.

Requirements

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and more than 4 years of pharmaceutical or biotechnology industry experience, or a PhD with more than 2 years of relevant experience.
• Strong knowledge of clinical trial design and analysis, statistical inference, hypothesis testing, parametric and non-parametric methods, sample-size calculations, and Phase II–IV clinical trial data analysis.
• Proficient SAS and R programming skills, with a solid understanding of CDISC models and standards.
• Knowledge of ICH guidelines, drug-development regulations, statistical contributions to marketing applications, and related regulatory requirements.
• Excellent written and verbal communication, interpersonal, leadership, time-management, and independent-working skills.
• Strong attention to detail and the ability to work effectively in a fast-paced, flexible, team-oriented environment.

Nice to have

• Knowledge of oncology or hematology therapeutic areas.
• Experience with Bayesian methods and adaptive trial designs.
• Experience in Phase I/II oncology studies or Phase I healthy-volunteer and clinical-pharmacology studies in neuroscience.

Culture & Benefits

• Remote/home-based work arrangement for the listed locations.
• Collaborative work across clinical development and supporting functions.
• Opportunity to contribute to patient-focused research and innovative therapeutics.
• Equal opportunity employment environment.