Senior Principal Statistician (Biostatistics)

Location: Remote/Home-Based for US-based candidates only; associated locations are Palo Alto, California and Philadelphia, Pennsylvania.

Base salary: $156,000–$234,000 annually, with potential discretionary bonus, incentive compensation, and equity grants.

Company

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

What you will do

• Lead statistical activities for individual clinical studies, related studies, integrated summaries, and regulatory filings across Phases I–IV.
• Design clinical studies, optimize endpoints and analysis strategies, and support protocol development and implementation.
• Write and review statistical analysis plans, perform and oversee analyses and validation, and interpret study results.
• Develop statistical programs in SAS and R for simulations, analyses, data displays, and verification of programming deliverables.
• Act as a statistical subject matter expert for clinical reports, integrated summaries, regulatory submissions, and agency interactions.
• Manage external statistics and programming vendors, including reviewing timelines, analysis plans, and CRO deliverables.

Requirements

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and more than 4 years of pharmaceutical or biotechnology experience, or a PhD with more than 2 years of relevant industry experience.
• Strong knowledge of clinical trial design and analysis, statistical inference, hypothesis testing, sample size calculations, and parametric and non-parametric methods.
• Proficient SAS and R programming skills, with a solid understanding of CDISC models and standards.
• Knowledge of drug development regulations, ICH Guidelines, and statistical contributions to marketing applications.
• Excellent written, verbal, interpersonal, communication, leadership, and time-management skills; ability to work independently.
• Strong attention to detail and 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 clinical trial designs.
• Knowledge of additional statistical applications or programming languages.

Culture & Benefits

• Cross-functional collaboration with clinical development, pharmacology, pharmacovigilance, regulatory affairs, medical writing, data management, and clinical operations.
• Remote/home-based work arrangement for eligible US-based candidates.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan and flexible paid vacation.
• Potential annual cash bonus or incentive compensation and discretionary equity grants.