Director of Biostatistics

$200k - $250k

Full-time

Astera Search

Role Description

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

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

Qualifications

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

Requirements

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

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Vacancy posted 3 hours ago

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