Biostatistics Senior Manager (Biosimilars)

Location: Remote in the United States; salary scope excludes Puerto Rico

Company

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

What you will do

• Lead statistical strategy, design, analysis, and reporting for a large product, complex studies, or multiple projects.
• Develop and review protocols, randomization specifications, Statistical Analysis Plans, TLG shells, SDF specifications, clinical study reports, and regulatory documentation.
• Oversee statistical work performed by CRO partners in a full-service CRO model.
• Perform analyses and exploratory investigations, drawing conclusions and recommendations for development teams.
• Represent Biostatistics in multidisciplinary teams and provide guidance on study design, data collection, and clinical documentation.
• Contribute to process improvement, scientific publications, regulatory interactions, and statistical methodology presentations.

Requirements

• Doctorate degree with at least 2 years of Biostatistics experience, or Master's degree with 6 years, or Bachelor's degree with 8 years.
• Advanced experience in Statistics or Biostatistics and post-graduate statistical work in pharmaceutical industry or medical research.
• Knowledge of biosimilar development and non-inferiority or equivalence trials.
• Experience with regulatory submissions, adaptive designs, and complex clinical study development.
• Ability to independently lead study design, analysis, and reporting and defend statistical findings to internal and external audiences.
• Effective written and oral communication and experience working with global teams and CRO partners.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time off and flexible work models where applicable.
• Career development opportunities and support for professional well-being.