Principal Biostatistician (Biotech)

Location: Onsite in Dunkirk, New York, United States. Monday–Friday during standard business hours, with flexibility subject to manager approval.

Annual base pay: $175,000–$195,000, depending on qualifications, experience, and geographic location. The position is also eligible for a discretionary bonus and equity award.

Company

hirify.global is a commercial-stage biotechnology company developing immunotherapies, cell therapies, vaccines, and other treatments for cancer and infectious diseases.

What you will do

• Lead statistical strategy for one or more clinical development programs from study design through regulatory submission.
• Design clinical trials, including sample size calculations, randomization, interim analyses, and Data Monitoring Committee activities.
• Develop and review clinical trial protocols, clinical study reports, and statistical analysis plans.
• Guide the creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs.
• Lead electronic submissions and data standardization activities, including CRF and database design, edit checks, CDISC standards, and standard statistical programs.
• Collaborate with clinical, regulatory, data management, and medical affairs teams while mentoring junior biostatistics staff.

Requirements

• Bachelor’s degree in Statistics or Biostatistics with 10+ years of relevant experience, or a master’s degree with 8+ years of relevant experience.
• At least 5 years of biostatistics experience in the biotechnology or pharmaceutical industry.
• Experience serving as a lead biostatistician across several concurrent projects.
• Experience with CDISC SDTM and ADaM standards.
• Working knowledge of clinical research, Good Clinical Practice, and regulatory requirements.
• Proficiency in SAS, familiarity with sample size software such as nQuery or PASS, and excellent English communication skills.

Nice to have

• Knowledge of adaptive trial designs, Bayesian methods, or other complex innovative designs.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities in a growing publicly traded biopharmaceutical company.
• Medical, dental, and vision plan options, along with health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability coverage, and employee assistance programs.
• Paid time off, holidays, education savings support, legal services, identity theft protection, pet insurance, and employee discounts.