Senior Quality/Regulatory Biostatistician

The Biostatistician will provide statistical expertise for regulatory submissions, including PMAs, 510(k)s, IDEs, and responses to regulatory agency queries. They will support Quality Assurance and Quality Improvement teams by analyzing manufacturing, post-market surveillance, and complaint data to identify trends, monitor performance, and drive corrective and preventive actions. Responsibilities include designing and implementing statistical methods for quality monitoring, collaborating with cross-functional teams to design statistically sound protocols for clinical trials and real-world evidence studies, and developing and reviewing statistical analysis plans, protocols, and reports. The role ensures statistical methods and documentation meet FDA, EMA, and other global regulatory requirements, involves performing statistical analyses using SAS, R, or equivalent software, and contributing to internal audits and inspections by providing statistical justifications and documentation. Staying current with evolving regulatory guidelines and statistical best practices is also a key responsibility.