Samruddhi Kanse

About Samruddhi Kanse

Biostatistical Skills :Bio-Statistical knowledge: Types of Data, Confidence Interval, P- value, Type I/II Error Randomization scheduleSample Size calculationVarious parametric and non-parametric biostatistical testsConclusion & interpretation of Statistical results Pharmacokinetic parameters Bioavailability and Bioequivalence analysis Understanding of Protocol, CRF, SAP (Statistical Analysis Plan), and Mockshells.Knowledge of 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 dataExpertise in SAS/Base with basic knowledge of PROC SQL and MACRO Import-Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, and PROC PRINT statements.Conditional statements like If-else, If-then, then do Where, AND, OR.SAS Functions like SUM, ROUND, SCAN, STRIP, PUT, CONCATENATE, CAT, SUBSTR, LENGTH, INPUT, and COUNT. Statements like SET, BY, MERGESAS/ODS process to create useful outputs in different formats. Statistical SAS Programming: PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC SORT, PROC CONTENTS, PROC ttest, PROC GLM, PROC NPAR1WAY, PROC PLAN.Clinical trial reports: PROC REPORT, Tables, Listings and Figures(TLF). Good knowledge of CDISC Standard-SDTM & ADAM and Regulatory requirements. Making TLF of Demographics and Adverse eventsKnowledge of R programming:Data Manipulation v Control Structures, functions Exploratory Data AnalysisStatistical Data Analysis using Parametric & Non-Parametric testsCreating Reports in RPower & Sample size SQL using RData Visualization, Analysis and PresentationCreating PPT using RSoftware: SAS, R, Minitab, LaTex, MS-Office

Experience

1. Biostatistician

   Lupin

   Apr 2022 — Present · Pune, IN

   Worked independently as a Biostatistician on multiple Studies.Reviewed study protocols and provided statistical inputs for the Statistical Analysis section.Prepared Statistical Analysis Plans (SAPs).Developed randomization schedules as per study design using SAS.Authored and maintained Standard Operating Procedures (SOPs) for Biostatistics activities.Performed statistical analysis by writing validated programs using SAS.Prepared Tables, Listings, and Figures (TLFs) for clinical data presentation.

Education

• Savitribai Phule Pune University

  Master's degree in Statistics

• Punyashlok Ahilyadevi Holkar Solapur University, Solapur

  B.Sc Statistics