Biostatistics Senior Manager (Biosimilars)

Location: United States - Remote

Salary: USD 154,104.15–208,493.85 annually

Company

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

What you will do

• Lead statistical strategy, study design, analysis, and reporting for a large product or complex biosimilar development projects.
• Develop and review protocols, randomization specifications, Statistical Analysis Plans, TLG shells, submission data specifications, clinical study reports, and regulatory documentation.
• Oversee statistical work performed by CRO partners in a full-service CRO model.
• Perform analyses across multiple studies, including exploratory analyses, and provide conclusions and recommendations.
• Represent Biostatistics on multidisciplinary project teams and provide statistical input into clinical data collection and study design.
• Identify resource and quality risks, support process improvement, and contribute to scientific publications and presentations.

Requirements

• Doctorate degree and 2 years of biostatistics experience, or a master’s degree and 6 years of experience, or a bachelor’s degree and 8 years of experience.
• Statistical experience in the pharmaceutical industry or medical research, with advanced training in statistics, biostatistics, or a related quantitatively focused subject.
• Knowledge or experience in biosimilar development, non-inferiority or equivalence trials, and statistical contributions to regulatory submissions.
• Experience with adaptive designs, including group sequential, treatment-arm selection, Bayesian adaptive, or combined-phase designs.
• Ability to independently lead complex studies or multiple less complex projects and provide strategic statistical guidance.
• Ability to work with global teams and CRO partners and communicate statistical findings to internal and external stakeholders.

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.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable.