Biostatistics Senior Manager, Biosimilars US- Remote

Senior Manager in Biostatistics will lead statistical strategy and execution for biosimilar products and complex studies, overseeing CRO partnerships and ensuring quality standards across protocols, analysis plans, and regulatory submissions. The role involves directing statistical analysis, contributing to clinical documentation, and collaborating across functional teams to advance biosimilar development initiatives.

Responsibilities

• Lead statistical strategy, study design, and analysis approaches for biosimilar products and complex studies
• Develop and oversee statistical documentation including protocols, SAPs, TLGs, CSRs, and regulatory submissions
• Manage and oversee statistical work performed by contract research organizations in full-service model
• Conduct statistical analysis of multiple studies and exploratory analyses with sound recommendations
• Represent biostatistics function in multidisciplinary teams and collaborate across functional areas

Requirements

• Doctorate in statistics/biostatistics with 2+ years pharmaceutical experience, or Master's with 6+ years, or Bachelor's with 8+ years
• Knowledge of biosimilars development and non-inferiority or equivalence trial design
• Experience with statistical contributions to regulatory submissions
• Expertise in adaptive design methodologies and complex study analysis
• Demonstrated ability to lead study design, analysis, and reporting independently
• Strong written and oral communication skills for internal and external audiences