Karishma Patil
Biostatistician @Syngene International Limited
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WORK HISTORY
Biostatistician @Syngene International Limited
Bengaluru, IN
EDUCATION
North Maharashtra University
Bachelor of Science - BS
North Maharashtra University
MSc
ABOUT KARISHMA PATIL
Sample size calculation using SAS• Randomization schedule using SAS programming• Statistical Analysis Plan (SAP) for clinical trials• Various parametric & non-parametric bio-statistical tests: t-test, ANOVA, ANCOVA, Chi-square, F-test, Sign test• Conclusion & interpretation of statistical results• Knowledge of various statistical methods useful in BE & Clinical trials• Projects:(1) Calculation of Pharmacokinetic parameters & Bioequivalence analysis (2x2 crossover design) & (2) clinical trial statistical analysis• Basic knowledge of SOP & Guideline terminology• Application of Statistics in Design Of Experiments (DOE) according to ICH Q8 GuidelinesKnowledge of basic SAS programming:• Data management: Concatenating, Merging, Handling missing values, Reading raw data files, creating data structures, Handling data and programming errors, Accessing data, Appending data and managing data.• Expertise in SAS/BASE with basic knowledge of PROC SQL and MACRO• Import-Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements• SAS/ODS process to create useful outputs in different formats• Statistical analysis: PROC GLM, PROC MIXED, PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC REG, procttest, proc npar1way for various statistical analyses• Clinical trial Report: PROC REPORT, Tables, Listings and Figures (TLF)• Basic knowledge of CDISC Standard- SDTM & ADaM and Regulatory Requirements.
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