The role involves designing, analyzing, and interpreting clinical trials and post-marketing surveillance in compliance with regulatory requirements
Job Summary
The role involves designing, analyzing, and interpreting clinical trials and post-marketing surveillance in compliance with regulatory requirements.
Candidates must provide scientifically rigorous statistical input into study design, analysis plans, and interpretation of results for drug development projects.
The position requires effective collaboration with global therapeutic area statisticians and the ability to influence regulatory guideline content.
Matching Summary
The role involves designing, analyzing, and interpreting clinical trials and post-marketing surveillance in compliance with regulatory requirements.
Skills & Requirements
Must-have
Clinical trial design and analysis
Statistical analysis plan development
Regulatory compliance with FDA guidelines
Cross-functional team collaboration
Scientific report and publication support
Nice-to-have
Strong communication skills in English
Experience influencing regulatory guidelines
Research on statistical methodology
Leadership in cross-functional activities
Knowledge of clinical medicine
Key Requirements
Master's degree or higher in Statistics or Biostatistics