I can provide statistical expertise during all phases of clinical development
- Clinical development plan
- Study design
- Input to protocols, including design, choice of estimand, sample size, randomization
- Preparation or review of the statistical analysis plan (SAP)
- Study conduct
- Participation in trial team
- Review and cleaning of data
- Planning of process
- Study reporting
- Statistical analyses according to the SAP
- Interim analyses
- Pharmacokinetic analyses
- Post-hoc analyses
- Input to and review of the clinical study report
- Regulatory meetings
- Preparation and attendance at agency meetings
- Submission
- Planning, preparation and review
- Statistical analyses
- Input to and review of the submission documents
- Questions and answers
- Publications
- Primary publication for studies
- Exploratory publications