Professional Experience Summary: ? Medical areas: Oncology, Anaesthesiology, Infectious diseases, Surgery, Gynaecology, Orthopaedics, Pathology, Clinical trial, paediatric, Nursing, Radiation oncology, Medical media, Epidemiology, Public Health Sciences. ? Type of studies & trials: Phase I & II, RCT Phase II & RCT Phase III clinical trials, Adaptive and advance study design, PK & PD studies, epidemiological studies, retrospective & perspective. ? Activities: ? Trial design (cross-over, parallel, single arm). ? Clinical trial design/planning, inputs to protocol. ? Statistical analysis plan(SAP), sample size & power calculation. ? Reporting activities including survival analyses, time series, analyzing real medical data with longitudinal, biomarker data, meta analyses, IPD & Network meta analyses, systematic review ,performed interim & futility analyses while maintaining double-blind aspect of trials, safety & efficacy analyses, confirmatory & exploratory analysis. ? Knowledge of SOP, additional analysis to support publications (& thesis). ? Designed & composed clinical protocol & case report forms. Created & managed clinical databases. ? Attended project team meetings, worked with Data Managers, Principle Investigators & Clinical Research Managers as appropriate. Reviewed & provided feedback for Data Integrity Plans. ? REDCap (Research Electronic Data Capture) for managing online database. ? Centralized randomization & randomization schedules. Develop simple analysis strategies, & execute them using efficient programming techniques. ? Followed standards: ICH Ex guidelines, CONSORT, RECIST 1.1, FDA E9. ? Proficient in Statistical computing: R: +4yrs, SAS: +2yrs, SPSS: +4yrs, STATA: +4yrs, PASS 19: +2yrs, East® 6.5: +2yrs.