Director Of Biostatistics

Description:

Morgan Prestwich is privileged to confirm that we have started working with an inspiring young clinical-stage company looking to make an incredibly positive impact on society and young families across the globe with it's latest treatment for rare diseases providing strategic expertise to their statistics department.

Our client is looking for a well-seasoned Director for the Biostatistics team with the hunger and ability to galvanize their department whilst working cross-functionally with internal and external partners to provide accurate and detailed regulatory submissions meeting all legal and quality requirements.

RESPONSIBILITIES:

• Creating, implementing, and maintaining relevant protocols and procedures
• Designing and overseeing all development of the biostatistical studies from phases 1-3
• Work cross-functionally with key stakeholders to ensure accurate regulatory submissions
• Conduct and provide statistical analysis with your team for clinical study reports
• Partner and manage CROs and vendors
• Maintain and improve database designs to ensure the storage of accurate information and results

QUALIFICATIONS & EXPERIENCE:

• PhD in Statistics
• 8+ years of experience in the life science industry working in Biostatistics
• Experience in preparing for NDAs, including relevant documents
• Broad and in-depth knowledge of FDA guidelines
• Great understanding and practical experience with statistical software and techniques