We do not believe in Entry Level training for Biostatistician. You need to gain enough knowledge in statistics applied in clinical trials. Position level is rewarded overtime with quality of your performance and deliverables. Experience in terms of number of years is irreverent. Bottom line is what you know and how you deliver. You need to be dependable, proactive and a good communicator.
- Protocol Statistical Section :
- Efficacy endpoints definition
- Safety parameters
- Study design
- Sample size calculations
- Statistical methodology
- Randomization procedure
- Statistical Analysis :
- Statistical Analysis Plan
- Safety and Efficacy Tables, Listings, and Graphs (TLGs) layouts
- Derived variables specification, visit windows algorithm
- Handling missing data
- Interim Analysis
- Sub-group analysis
- Program inferential statistical tables
- Exploratory analysis – interactions, testing model assumptions
- Sensitivity analysis for robustness of study results (specially for dropouts)
- Ad hoc analysis to support marketing and publication
- Common methods for analysis of clinical data with continuous, categorical, and time to event endpoints
- Validation of Tables, Listings and Figures :
- Write independent SAS code for validation
- Write validation documents
- Integrated Analysis
- Mentoring: one-on-one, evaluation, and guidance
