The role involves providing scientifically rigorous statistical input into study design, analysis plans, and interpretation of results for drug development projects
Job Summary
The role involves providing scientifically rigorous statistical input into study design, analysis plans, and interpretation of results for drug development projects.
Candidates must ensure all statistical activities comply with relevant regulatory requirements and company standards while collaborating with global therapeutic area statisticians.
The position requires accountability for statistical deliverables including clinical study reports and support for regulatory submissions and publication activities.
Matching Summary
The role involves providing scientifically rigorous statistical input into study design, analysis plans, and interpretation of results for drug development projects.
Skills & Requirements
Must-have
Clinical trial design and analysis
Statistical analysis plan development
Regulatory compliance and SOP adherence
Cross-functional team collaboration
Scientific report preparation
Nice-to-have
Strong statistical leadership capabilities
Research on statistical methodology
Influence on regulatory guidelines
Effective verbal and written communication
Key Requirements
Master's degree or higher in Statistics or Biostatistics
Advanced English communication skills
Knowledge of clinical medicine and regulatory requirements