Pulse Biosciences

Manage and monitor clinical study activities at US and international sites to ensure successful execution and data validity. Ensure all duties comply with FDA CFR and ICH-GCP guidelines while overseeing patient recruitment and regulatory documentation.

The Sr. Biostatistician provides advanced statistical expertise to design, conduct, and analyze clinical studies for medical device safety and efficacy. This includes developing statistical methodologies, creating analysis plans, and preparing reports for regulatory submissions to authorities like the FDA.

Develop, write, and edit high-quality clinical and regulatory documentation to support the development and registration of medical devices. Collaborate with cross-functional teams to interpret clinical data and ensure compliance with global regulatory standards.

The Therapy Development Manager is responsible for driving product adoption, clinical utilization, and account business viability for the nPulse Vybrance system within an assigned region. This includes providing technical training, supporting clinical procedures, managing reimbursement processes, and building relationships with key opinion leaders and medical staff.