HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.
We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.
Location: Remote - Contiguous United States
Travel: 10-20%
Position Summary (Why this role matters):
We are seeking a highly skilled and experienced Clinical Data Scientist to aid with 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 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 (What you’ll do):
- Aid with the statistical design, analysis, and reporting of clinical study data (pre-market feasibility, pre-market pivotal, post-market, observational, and RWE) under guidance from the principal clinical data scientist and senior leaders.
- 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.
- 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.
- Work 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
- Work with key stakeholders to ensure appropriate data elements are captured during CRF development
- Partner with R&D, Professional Education and Medical Affairs to aid in procedure development for new indications
- Support the planning and coordination of clinical advisory boards to guide research activities as needed
- Assist the Regulatory Affairs and Quality Assurance teams in preparation for reporting and submissions
- May assist in internal and external audits
- Develop and maintain strong relationships 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 5 years of experience in clinical research or a minimum of 7 years of experience in clinical research
- 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
- 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.
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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Skills Required
- Master's degree in a relevant technical or scientific field (public health, epidemiology, statistics, data science, etc.)
- Minimum of 5 years of experience in clinical research
- Understanding of clinical trial design and regulatory guidelines (FDA, EMA, ICH-GCP) and data standards (CDISC)
- Familiarity with statistical analysis software (SAS, R)
- Familiarity with data visualization tools (Tableau, Spotfire, R Shiny, Python Dash)
- Strong analytical, critical thinking, and problem-solving skills
- Excellent written and verbal communication skills and ability to explain complex technology clearly
- Leadership, project management, and ability to prioritize multiple tasks and deadlines
- Contributions to publications, regulatory submissions, or clinical development strategy
- Experience in oncology, rare diseases, or other high-impact therapeutic areas
What We Do
HistoSonics is a growth phase company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy. Histotripsy utilizes the pressure created by focused sound energy to liquefy and destroy targeted tissue, including diseased tissue and tumors, at sub-cellular levels. The company’s new platform delivers personalized, tissue specific treatments with precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities. HistoSonics is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, MI, Madison, WI, and Minneapolis, MN.
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