Note: The job is a remote job and is open to candidates in USA. HistoSonics, Inc. is a commercial-stage medtech company advancing innovative sonic beam therapy for medical applications. They are seeking a Clinical Data Scientist to design, analyze, and interpret complex clinical data across various studies, ensuring robust methodologies and compliance with regulatory standards.
Responsibilities
- 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
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
- Comprehensive benefits package for full-time employees
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability insurance
- Long-term disability insurance
- 401(k)
- Paid time off
- More
Company Overview
Company H1B Sponsorship