Take charge as a Principal Biostatistician leading statistical initiatives in Oncology and CNS trials. Collaborate with cross-functional teams to deliver high-quality statistical outputs that meet regulatory standards.
In this senior role, the Principal Biostatistician provides oversight on numerous statistical projects. With a minimum of 7 years in the Pharma/Biotech industry, you will leverage your expertise in CDISC, FDA, and ICH regulations to drive project success. Your leadership will guide the statistical methodologies and ensure compliance with established standards.
Key Responsibilities:
• Act as the lead Biostatistician and project manager
• Interface with sponsors for requirements and timelines
• Author Statistical Analysis Plans and reports
• Manage ADaM package development and reviews
• Recommend methodologies for clinical trial analyses
Requirements:
• MSc. or PhD. in Biostatistics or Statistics
• 7+ years in Biostatistics in Pharma/Biotech