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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
Vacancy posted 9 hours ago
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