Senior Director, Biostatistics (Biosimilars)

Location: United States - Remote

Salary: USD 223,624.80–302,551.20 per year

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide strategic statistical leadership across all phases of biosimilar development, including study design, analysis, reporting, and clinical development planning.
• Oversee protocols, Statistical Analysis Plans, clinical study reports, regulatory submissions, health-authority correspondence, publications, and reimbursement documents.
• Develop innovative methodologies and study designs for non-inferiority and equivalence trials.
• Lead, manage, hire, and develop internal biostatisticians while overseeing biostatistical work performed by CROs.
• Represent Biosimilar Development in discussions with regulatory authorities, key opinion leaders, academics, and other expert bodies.
• Contribute to policies, SOPs, operational improvements, scientific publications, and external presentations on statistical methodology.

Requirements

• Doctorate degree and 5 years of Senior Director, Biostatistics experience; or master’s degree and 9 years; or bachelor’s degree and 11 years.
• At least 5 years of direct people management or leadership experience overseeing teams, projects, programs, or resource allocation.
• Experience in statistical leadership for regulatory submissions and clinical development.
• Experience in pharmaceutical industry or medical research, including drug development from pre-clinical through post-marketing stages.
• Knowledge of biosimilar development, global regulatory requirements, and the design and analysis of non-inferiority and equivalence trials.
• Must be based in the United States.

Nice to have

• Doctorate in Statistics or Biostatistics with at least 8 years of post-graduate statistical experience, or a master’s degree with at least 10 years.
• Strong leadership, communication, people-management, and team-building skills.
• Experience working with global teams and CRO partners to improve operational efficiency.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Opportunity to contribute to medicines for serious illnesses and impact patient lives.
• Full-time remote work within the United States.