HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.
Location : Remote, USA
Travel: 10% (Occasional company meetings, a couple days at a time.)
Position Summary
We are seeking a highly skilled and experienced Senior Clinical Data Scientist to lead the design, analysis, and interpretation of complex clinical data across clinical trials, real-world evidence (RWE), and observational studies for medical devices. The ideal candidate will bring expertise in clinical study design, biostatistics, and data science, combined with strong knowledge of clinical research processes and regulatory requirements that govern medical devices. This role will play a critical part in driving data-driven insights to inform product development, clinical decision-making, regulatory submissions, and manuscript development.
Key Responsibilities
Clinical Data Strategy & Analysis
Data Management & Oversight
Cross-functional Collaboration
Leadership & Mentorship
Mentor clinical affairs interns.
Represent the company in scientific forums, regulatory discussions, and cross-industry initiatives.
Works with key stakeholders to design clinical studies that meet key business objectives which may include the following:
Collect clinical safety and performance data to meet regulatory requirements in key regions
Collect clinical data to meet post-market requirements (e.g., CPT code applications, marketing claims, etc.)
Collect clinical data to meet pre-market requirements
Works with key stakeholders to ensure appropriate data elements are captured during CRF development
Partners with R&D, Professional Education and Medical Affairs to aid in procedure development for new indications
Supports the planning and coordination of clinical advisory boards to guide research activities as needed
Assists the Regulatory Affairs and Quality Assurance teams in preparation for reporting and submissions
May assist in internal and external audits
Develops and maintains strong relationship with physician collaborators
Qualifications And Skills
Nice To Have
Salary Range : $125,000-170,000, plus bonus.
Benefits : We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.