Biostatistics & Programming

Biostatistics and statistical programming provide the analytical foundation for clinical trial design, analysis, and interpretation. These functions support evidence generation throughout development and regulatory submission.

Biostatistical activities include study design input, analysis planning, and data interpretation, while programming supports the creation of analysis datasets and tables, listings, and figures. Close collaboration between statisticians, programmers, and clinical teams is essential.

High-quality statistical support contributes to reliable results and defensible regulatory submissions.

Biostatistics and programming activities commonly include:

• Statistical analysis plan development

• Clinical trial design support

• Dataset creation and validation

• Statistical analysis and reporting