Role Summary

Reporting to the Head of Biometrics, the Associate Director, Biostatistics will serve as a key statistical leader across the portfolio. This individual will act as both an internal subject matter expert and an external representative of the company in regulatory and collaborative settings.

Responsibilities

• Offer input into strategic trial design
• Collaborate with internal groups, cross-functionally
• Oversee external vendors and CRO relationships
• Complete modelling to explore appropriate statistical trial designs and approaches
• Author or review the statistical sections of the clinical trial protocol
• Create and review Statistical Analysis Plans (SAPs)
• Provide input into other clinical trial documentation as required
• Complete ad hoc analysis as required by the business and respond to statistical questions from regulatory authorities
• Support regulatory activities associated with submissions
• Co-represent the business externally, in meetings with regulatory authorities and other parties

Experience required:

• PhD, or Masters with supplementary experience
• Demonstrable experience in a leading role in submissions (MAA, NDA, IND, etc.)
• Have interacted with regulatory authority interactions
• Well versed working with external CRO/Vendor partners
• Strong communication skills, both written and oral, and a keen ability to communication statistical concepts to non-statistically minded individuals.

Salary based on experience between $190,000 and $240,000