Biostatistics Senior Manager, Biosimilars US- Remote
Core
Lead statistical aspects for clinical activities and documentation for a single large product or complex studies in biosimilars development.
Role type
Senior Manager, Biostatistics (Biosimilars)
Builds
Clinical Study Reports, regulatory submissions, and statistical documentation for biosimilar medicines.
Domain
Biotechnology / Biosimilars / Clinical Statistics
Required skills
Biostatistics, study design, statistical analysis, regulatory guidelines, CRO management, adaptive designs, non-inferiority/equivalence trials
Preferred skills
Biosimilars development, combined phase designs, strategic statistical input, defending statistical findings, global team collaboration
Technologies
SAS, R, Python (implied by standard biostats tools, though not explicitly listed, omitted per strict instruction to only list stated tools; none explicitly stated)
Responsibilities
Oversee statistical work performed by CROs; plan and execute statistical contributions to protocols and SAPs; perform statistical analysis of multiple studies; participate in multidisciplinary project team meetings; review CRO policies and SOPs.
Seniority
Senior Manager, hands-on IC with leadership