Clinical Data Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the statistical design, analysis, and reporting of clinical study data (including pre-market feasibility, pivotal studies, post-market, observational, and real-world evidence).

• Collaborate with clinical, medical, and regulatory teams to ensure that study objectives are achieved using robust statistical methodologies.

• Create innovative data science strategies (such as predictive modeling and machine learning/artificial intelligence) to enhance clinical trial optimization and patient outcomes research.

• Supervise data quality, integrity, and compliance with regulatory standards (FDA, EMA, ICH-GCP).

• Work together with Data Management teams on the design of case report forms, data cleaning, and database lock processes.

• Ensure data traceability, reproducibility, and compliance with relevant data standards.

• Provide insights from data science for clinical development plans, study protocols, and statistical analysis plans (SAPs).

• Assist in the preparation of publications, abstracts, and presentations with high-quality outputs.

• Guide clinical affairs interns through mentorship.

• Represent the organization in scientific forums, regulatory discussions, and cross-industry initiatives.

⛳️ Requirements

• A Master’s degree in a relevant technical or scientific discipline (such as public health, epidemiology, statistics, data science, etc.).

• At least 5 years of experience in clinical research, or a minimum of 7 years in a relevant field.

• Knowledge of clinical trial design, regulatory guidelines (FDA and Global), and data standards (CDISC, ICH, FDA/EMA requirements).

• Exceptional analytical, critical thinking, and problem-solving abilities.

• Proficiency in statistical analysis software (such as SAS, R).

• Familiarity with data visualization tools (Tableau, Spotfire, R Shiny, Python Dash).

• Experience contributing to publications, regulatory submissions, or clinical development strategies.

• Background 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) plan.

• Paid time off.

• A vibrant and exciting work culture.