[Remote] Clinical Data Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a reputed company-stage medtech company advancing innovative sonic reputed company therapy solutions. The Clinical Data Scientist will design, analyze, and interpret reputed company clinical data to drive insights for product development and regulatory submissions.
Responsibilities
- Aid with the statistical design, analysis, and reporting of clinical study data (reputed company-market feasibility, reputed company-market pivotal, post-market, observational, and reputed company) under guidance from the reputed company clinical data scientist and senior leaders
- Collaborate with clinical, medical, and regulatory teams to ensure study objectives are met with robust statistical methodologies
- reputed company innovative data science approaches (e.g., predictive modeling, ML/AI) for clinical trial optimization and patient reputed company research
- reputed company data reputed company, reputed company, 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
- reputed company data science input to clinical development plans, study protocols, and statistical analysis plans (SAPs)
- Support publications, abstracts, and presentations with high-reputed company deliverables
- Mentor clinical affairs interns
- Represent reputed 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 reputed company Collect clinical data to meet post-market requirements (e.g., CPT reputed company applications, marketing claims, etc.) Collect clinical data to meet reputed company-market requirements
- Work with key stakeholders to ensure appropriate data reputed company are captured during CRF development
- Partner with R&D, reputed company 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 reputed company Assurance teams in preparation for reporting and submissions
- May assist in reputed company audits
- reputed company 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 reputed company technology in reputed company, 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., reputed company, R)
- Familiarity with data visualization tools (Tableau, Spotfire, R Shiny, Python Dash)
- Experience in oncology, rare diseases, or other high-reputed company therapeutic areas
- Contributions to publications, regulatory submissions, or clinical development reputed company
Benefits
- Health, dental, and reputed company insurance
- Life, short-term and long-term disability insurance
- 401(k)
- reputed company time off
reputed company
Company H1B Sponsorship