How You’ll Spend Your Day:
- Study Protocol Review: Review study protocols of BA/BE (Bioavailability/Bioequivalence) studies and provide inputs in the pharmacokinetic (PK) and statistical analysis sections to ensure accuracy.
- SOP Preparation: Prepare Standard Operating Procedures.
- Sample Size Justification: Estimate and justify sample sizes.
- Randomization Schedules: Prepare and review randomization schedules as per study design using SAS software.
- PK Parameter Estimation: Estimate PK parameters using Phoenix WinNonlin software.
- Statistical Analysis: Perform statistical analysis for PK parameters applying appropriate methods using SAS software.
- Statistical Report Preparation: Prepare and review statistical reports.
- Clinical Study Report Review: Review clinical study reports and provide inputs on the PK and statistical analysis sections.
- Query Clarifications: Provide clarifications on statistical queries from sponsors and regulatory authorities.
