Sr. Principal Statistician, Biostatistics

Location: Remote/Home-Based in the United States; Philadelphia, PA

Base salary: $156,000–$234,000 per year for US-based candidates, plus potential bonus, incentive compensation, equity grants, and benefits.

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 or support the statistical design, analysis, validation, and reporting of Phase I–IV clinical studies and regulatory filings.
• Develop study protocols, statistical analysis plans, simulations, analyses, data displays, and clinical study documentation.
• Collaborate with clinical development, pharmacology, pharmacovigilance, regulatory affairs, medical writing, data management, clinical operations, and project management.
• Review study-specific data capture systems, validate analyses, and verify data accuracy and deliverables.
• Oversee external statistics and programming vendors, monitoring the quality and timeliness of CRO deliverables.
• Prepare for regulatory agency meetings, respond to statistical questions, and contribute to clinical reports and integrated summaries.

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 in a related discipline.
• Knowledge of clinical trial design and analysis, statistical inference, hypothesis testing, sample size calculations, parametric and non-parametric methods, and Phase II–IV clinical trial data.
• Proficient programming skills in SAS and R, with an understanding of CDISC models and standards.
• Knowledge of drug development regulations and applicable ICH guidelines.
• Strong writing, communication, interpersonal, leadership, attention-to-detail, and time-management skills.
• Must be a US-based candidate for this remote/home-based role.

Nice to have

• Knowledge of Bayesian and adaptive trial design.
• Experience with other statistical applications or programming languages.

Culture & Benefits

• Work in a flexible, fast-paced, and team-oriented environment.
• Participate in professional development through literature review, conferences, and continuing education.
• Benefits may include medical, dental, and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation.
• Work may occasionally require activity outside normal business hours to meet business demands.