Biostatistician Manager, Clinical Affairs (Hybrid)

The Biostatistician Manager, Clinical Affairs will lead the team and provide expert statistical support for internally sponsored, real-world evidence (RWE), and external clinical studies. The position requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry.

Requirements

• Lead and manage the biostatistics team
• Develop and implement statistical methodologies for sample size calculations and power analysis
• Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs
• Collaborate with cross-functional teams to ensure robust statistical support for product validation and claims
• Ensure compliance with regulatory requirements and industry standards for statistical practices

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• Additional employee wellness programs