Biostatistics Director (Oncology Biosimilars)

Location: United States - Remote; other listed locations include Houston, Chicago, Baltimore, Seattle, Newark, and Philadelphia.

Salary: $200,108.70–$270,735.30 annually.

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses, including cancer and rare diseases.

What you will do

• Lead statistical strategy, design, analysis, and reporting across early- to late-phase biosimilar development programs.
• Review clinical development plans, protocols, statistical analysis plans, clinical study reports, regulatory submissions, and scientific publications.
• Provide statistical leadership for regulatory strategies, health authority interactions, product defense, and market support.
• Represent the statistical function with regulatory authorities, key opinion leaders, CROs, and other scientific bodies.
• Hire, manage, mentor, and develop statistical staff while overseeing CRO deliverables, timelines, quality, budgets, and resources.
• Advance statistical methodologies, policies, SOPs, and operational practices within a biopharmaceutical setting.

Requirements

• Doctorate degree and 4 years of biostatistics experience, or master’s degree and 8 years, or bachelor’s degree and 10 years.
• Strong knowledge of statistical methodology and applications in drug development, particularly oncology.
• Experience providing statistical leadership for regulatory submissions and clinical development programs.
• Experience with adaptive designs, including group sequential, treatment-arm selection, Bayesian adaptive, or combined-phase designs.
• Experience across the drug development lifecycle and in leading high-performing teams.
• Must be eligible to work in the United States for this U.S.-remote role.

Nice to have

• Master’s or doctorate degree in Mathematics, Biostatistics, or Statistics.
• Ten years of post-graduate statistical experience in the pharmaceutical industry or medical research organizations.
• Experience working with global teams and CRO partners.
• Published applied research or presentations on statistical methodology.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus, stock-based long-term incentives, and paid time off.
• Career development opportunities and flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Visa sponsorship is not guaranteed.