Provide technical leadership for regulatory submissions.
Manage vendor relationships and internal SOPs.
Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. They embrace innovation and achieve results through cooperation and the integration of multiple viewpoints, with a focus on radical care.
Act as the statistical lead for one or multiple projects.
Provide expert biostatistics input on development plans and study design.
Oversee the vendor/CRO biostatistics teams.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications. They are a fast-paced company committed to building an exceptional company culture, founded on their C.O.R.E. values.
Lead complex RWE studies and multi-protocol programs, providing end-to-end statistical oversight and coordination across teams and locations. Develop and review complex Statistical Analysis Plans, ensuring methodological soundness and regulatory alignment. Act as a subject matter expert, supporting internal initiatives, procedural documentation, and best practices.
This position is posted by Jobgether on behalf of a partner company.