Prime Medicine Benefits Overview

Serve as senior biostatistics leader providing study design, statistical methodology, regulatory interaction, and operational oversight for biometrics (biostatistics, data management, vendor programming) across gene editing clinical programs. Build and lead an integrated Biometrics function, manage CRO/vendor relationships, ensure data quality/CDISC standards, support regulatory submissions, and drive inspection readiness and SOPs.

Design and optimize Prime Editing strategies (pegRNA, protein and mRNA constructs) in vitro and transition to in vivo models. Execute structure-function studies, generate interpretable data, collaborate with cross-functional teams and CROs, support development candidate nomination, publish and patent findings, mentor junior staff, and maintain lab safety and accurate records.

Provide technical leadership for development, characterization, and scale-up of lipid nanoparticle (LNP) formulation and drug-product manufacturing processes. Drive process optimization, analytical characterization, GLP/GMP scale-up, and technology transfer to CDMOs. Support CMC regulatory documentation, maintain ELN records, author SOPs and reports, and communicate results cross-functionally to advance clinical programs.