Clinical Data Scientist

🕒 June 25

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HistoSonics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

HistoSonics, Inc. is a pioneering medical technology company that has developed a non-invasive sonic beam therapy platform using a treatment called histotripsy. This innovative approach harnesses focused ultrasound to mechanically destroy targeted liver tumors at a sub-cellular level. HistoSonics is dedicated to advancing the science of histotripsy, aiming to provide transformative benefits for patients and physicians worldwide, particularly through its ongoing clinical trials and educational programs.

📋 Description

• Aid with the statistical design, analysis, and reporting of clinical study data (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 • 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.

🎯 Requirements

• Master’s degree in relevant technical or scientific field (e.g. public health, epidemiology, statistics, data science, etc.) • 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 • 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

• Health, dental, and vision insurance • Life insurance • Short-term and long-term disability insurance • 401(k) • Paid time off • Exciting work culture