A well-established, secure and commercially active biopharma is growing its US biostatistics presence as it shifts to taking oncology assets all the way to market. This is a hands-on statistical leadership role, owning statistical strategy for a pivotal Phase III study and the wider oncology portfolio.

Responsibilities

Lead biostatistics for the oncology portfolio

Act as lead statistician on a pivotal Phase III study

Drive statistical strategy from early phase through to registrational trials, including adaptive and Bayesian designs where appropriate

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 with senior leadership

Support regulatory interactions, including IND, NDA/BLA submissions

Experience Required

PhD in Biostatistics or Statistics; Masters with supplementary experience considered

Extensive oncology experience

Demonstrable experience working directly for a sponsor company

Track record of supporting or leading regulatory submissions; FDA inspection experience a strong plus

Immuno-oncology or ADC experience a significant plus

Strong communication skills across statistical and non-statistical audiences

East Coast based only

Compensation DOE - $200,000 - $250,000 base salary + benefits