As a statistician working in drug development, I work at study level, project level and franchise level. I now work on clinical trials of three breast cancer drugs. I have been Hematology Franchise Biomarker Biostats Lead during 2013 - 2017. I have also led project level safety reporting from 2012 to 2014 for one molecular. Examples of activities include:
Clinical trials: work on phase I to phase III clincal trials includes designing trial, writing SAP (statistical analysis plan), authoring/contributing to the CSR (clinical study report) and papers
Hematology Franchise Biomarker Biostats Lead (June 2013 - Dec. 2017)
- worked closely with biomarker scientists to develop the biomarker strategy for the Hematology franchise
- provided consultation to individual statisticians (including study statisticians and project lead statisticians) on biomarker analysis
- led statistical analyses for projects with broader impact
- piloted R Markdown template for biomarker analysis
Lead statistician on project level safety reporting for one molecular (Aug. 2012 – Apr. 2014), including first RMP (Risk Management Plan) and SCS (Summary of Clinical Safety) for regulatory filing:
- drove strategic discussions in a cross-functional team
- led Biometric activities to ensure appropriate statistical methodology be applied and efficient delivery
Co-organized Bayesian Seminars and led sessions on “Conjugate Priors and DDCP (Data Driven Conditional Probability)” and “Bayesian Interim Analysis”. Developed R shiny applications for “Predictive Probability” and DDCP.