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:

• Lead the statistical design, analysis, and reporting of clinical studies (pre-market feasibility, pre-market pivotal, post-market, observational, and RWE).
• Collaborate with clinical, medical, and regulatory teams to ensure study objectives are met with robust statistical methodologies.
• Develop innovative data science approaches (e.g., predictive modeling, ML/AI) for clinical trial optimization and patient outcomes research.

• Oversee data quality, integrity, and compliance with regulatory standards (FDA, EMA, ICH-GCP).
• Partner with Data Management teams on CRF design, data cleaning, and database lock activities.
• Ensure data traceability, reproducibility, and adherence to relevant data standards.

• Serve as the subject matter expert for clinical data science across therapeutic areas.
• Provide data science input to clinical development plans, study protocols, and statistical analysis plans (SAPs).
• Support publications, abstracts, and presentations with high-quality deliverables.

• 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:

• Master’s degree in relevant technical or scientific field (e.g. public health, epidemiology, statistics, data science, etc.) and a minimum of 7 years of experience in medical device clinical research OR a Bachelor's degree with a minimum of 10 years of experience in medical device clinical research
• Strong understanding of clinical trial design, regulatory guidelines (FDA and Global), and data standards (CDISC, ICH, FDA/EMA requirements)
• Strong analytical, critical thinking, and problem-solving skills with the ability to interpret and analyze data
• Ability to discuss complex technology in clear, discernible terms
• Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow
• through skills.
• Strong leadership, problem-solving, and project management skills.
• Demonstrated record of converting strategic plans to prioritized product development, and/or
• operational objectives
• Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining
• communication with team and manager
• Excellent written and verbal communication skills

Nice to Have:

• Familiarity with statistical analysis software (e.g., SAS, R)
• Familiarity with data visualization tools (Tableau, Spotfire, R Shiny, Python Dash).
• Contributions to publications, regulatory submissions, or clinical development strategy.
• Experience in oncology, rare diseases, or other high-impact therapeutic areas.

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.

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