Jayesh Patil Email & Phone Number

Bio-Statistical Skills:• Sample size calculation.• Randomization schedule using SAS programming.• Statistical Analysis Plan (SAP) for clinical trials.• Mock TLGs for Clinical trials.• Knowledge about Survival Analysis.• Analysis of clinical data using t-test, ANOVA, ANCOVA, RMANOVA, Linear Regression, Chi-square, F-test, Sign test, logistic regression.• Handling of Missing values and partial dates, Visit Windowing.• Knowledge about Conclusion & interpretation of statistical outcomes derived from various statistical methods. • Knowledge of various designs of Clinical trials, applications of various statistical methods according to data, study objective, primary-secondary efficacy and safety parameters.• Basic knowledge of SOP & Guideline.•Statistical analysis using PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TTEST, PROC NPAR1WAY, PROC GLM, PROC MIXED, PROC PLAN, etc.Statistical programming Skills: • Assisted in the review and documentation of SDTM specifications and mappingdocuments, ensuring alignment with CDISC standards. Validated SDTM datasetsagainst CDISC standards using Pinnacle21. Assisted in the creation of SDTMdefine.xml.• Proficiently generated ADaM specification and creation of ADaM datasets.• Write SAS program for creation of Tables using SAP and Mock TLGs.• Generate utility macros to streamline data processing and analysis workflows, enhancing efficiency and accuracy across projects.