Associate Director, Biostatistics

We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. Key contributor on regulatory submissions and communication with global regulatory authorities and provide expert statistical advice. Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications. Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks.