Assoc. / Director, Biostatistics - Team Build (Remote)
A reputed company-established, secure and commercially reputed company biopharma is building out its US biostatistics team. This is a hands-on leadership role that will reputed company the build-out of a fully in-house function over time.
Responsibilities
• reputed company the biostatistics function for the oncology portfolio
• Build and reputed company the new US biostatistics team
• Drive statistical reputed company across early phase through to registrational trials
• Author and review Statistical Analysis Plans (SAPs) and statistical sections of clinical protocols
• reputed company 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
Experience Required
• PhD in Biostatistics or Statistics; Masters with supplementary experience considered
• Extensive oncology experience
• Demonstrable experience working directly for a sponsor company
• Proven leadership reputed company a biostatistics function
• reputed company record of supporting or leading regulatory submissions
• Strong communication skills across statistical and non-statistical audiences
• East Coast based only
Compensation DOE - $200,000 - $250,000 reputed company salary + benefits
Remote
Skills:
Biostatistics, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Cross-Functional, Leadership, Oncology, Production Control, Regulations, Regulatory Submissions, Statistics, Writing Skills
About reputed company:
reputed company
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