Clinical Data Scientist

Lead the design, analysis, and interpretation of clinical data across trials, real-world evidence, and observational studies to support medical device development and commercialization.

• Support statistical study design, analysis plans, and reporting for pre-market and post-market clinical studies under senior guidance.
• Partner with clinical, medical, regulatory, and data management teams to ensure study integrity, high-quality data collection, and regulatory alignment.
• Develop and apply advanced analytical methods, including predictive modeling and AI/ML approaches, to improve clinical insights and outcomes.
• Ensure compliance with global regulatory and data standards, including Food and Drug Administration requirements, European Medicines Agency expectations, and ICH-GCP principles.
• Collaborate on CRF design, database management, data cleaning, and ensuring reproducibility and traceability of datasets.
• Contribute to clinical development plans, regulatory submissions, scientific publications, and conference presentations.
• Support cross-functional initiatives with R&D, Medical Affairs, and Regulatory teams, including advisory boards and audit readiness.

Requirements:

Experienced clinical data scientist with strong expertise in biostatistics, clinical research methodologies, and data-driven decision-making within regulated environments.

• Master’s degree in statistics, epidemiology, public health, data science, or related field, with 5+ years of clinical research experience (or 7+ years equivalent experience).
• Strong understanding of clinical trial design, medical device development pathways, and global regulatory frameworks.
• Proficiency in statistical and analytical tools such as SAS, R, Python, and data visualization platforms (e.g., Tableau, Spotfire, R Shiny, Dash).
• Experience working with clinical data standards such as Clinical Data Interchange Standards Consortium and regulatory submission requirements.
• Ability to translate complex datasets into clear, actionable insights for clinical, technical, and executive stakeholders.
• Strong project management, prioritization, and cross-functional collaboration skills in fast-paced environments.
• Excellent written and verbal communication skills, with experience supporting publications, regulatory filings, or clinical strategy.
• Familiarity with therapeutic areas such as oncology, rare diseases, or other high-impact clinical domains is a plus.

Benefits:

• Competitive annual salary ($120,000–$140,000)
• Comprehensive health, dental, and vision insurance coverage
• Life insurance, short-term and long-term disability benefits
• 401(k) retirement savings plan
• Paid time off and holiday benefits
• Remote work flexibility within the United States
• Opportunity to contribute to cutting-edge clinical innovation in medtech and advanced therapies
• Equal opportunity workplace with a strong commitment to diversity and inclusion.