Data & Technology
Biostatistics & Programming
Statistical design, analysis and programming for interim analyses, final results and submissions.
What's Included
- Statistical design and sample size calculation
- Adaptive and two-stage designs
- Statistical Analysis Plans (SAPs) and mock shells
- Randomization schedules
- SDTM/ADaM datasets and define.xml
- Tables, listings and figures (TLFs)
- Interim analyses and DSMB/IDMC statistical support
- Integrated summaries of safety and efficacy (ISS/ISE)
- Submission-ready packages and reviewer guides
- Statistical input to CSRs and publications