A well-established, secure and commercially active biopharma is building out its US biostatistics team. This is a senior leadership role that will oversee the build-out of a fully in-house function.
Responsibilities

• Lead the biostatistics function for the oncology portfolio
• Build and develop the new US biostatistics team
• Drive statistical strategy across early phase through to registrational trials
• Author and review Statistical Analysis Plans (SAPs) and statistical sections of clinical protocols
• Oversee production of Tables, Figures, and Listings (TFLs) and clinical study reports
• Represent biostatistics cross-functionally and in interactions with regulatory authorities
• Support regulatory interactions, including IND, NDA/BLA submissions

• PhD in Biostatistics or Statistics; Masters with supplementary experience considered
• Extensive oncology experience
• Demonstrable experience working directly for a sponsor company
• Proven leadership within a biostatistics function
• Track record of supporting or leading regulatory submissions
• Strong communication skills across statistical and non-statistical audiences
• East Coast based only