Biostatistics & clinical trials
Statistical leadership from protocol to submission for sponsors, CROs and academic investigators.
- Study design and protocol development
- Statistical analysis plans (SAP), TLFs and CSRs
- Adaptive and group-sequential designs, interim analyses
- Sample size and power (EAST, PASS)
- Survival, time-to-event and recurrent-event analysis
- Mixed models, categorical and count data, Bayesian methods
- CDISC SDTM/ADaM; ICH E9 and E9(R1) estimands
- Regulatory responses, briefing books and CRO oversight
- Oncology
- Cell therapy
- Cardiovascular
- Respiratory
- Immunology
- Metabolic & diabetes
- Neuromuscular
