Yuvraj Katkar

About Yuvraj Katkar

A Competent Professional with 16+ years of experience in Clinical Analytics (Biostatistics and SAS)• Currently associated with Fortrea (Formerly Labcorp) as a Senior Principal Statistical Programmer• Knowledge of the Drug Development Process and regulatory guidelines like Good Clinical Practice (GCP), ICH guidelines• Hands on experience in the Therapeutic Areas: Rare Diseases (RWD/RWE), Hematology, Oncology, Immune MediatedInflammatory Disease (IMID - RA), and Diabetes• Experience in Analysing and Reporting of Clinical Trial Safety and Efficacy Data (Phase I - IV Trials)• Deft at understanding of CDISC SDTM and ADaM implementation guidelines• Development and Validation of SDTM, Analysis datasets, Tables, Listings and Figures in accordance with approvedstatistical analysis plan and shell displays. SAS program is to be written using Base SAS, SAS/STAT procedures or macros• Edit check programming to identify potential data issues and communicate the same to team and client• Effective organizational, communication, time management, project management and people management skills• Highly self-motivated and goal-oriented professional to work well both independently and in a team environment• Experience in Analysing and Reporting of drug concentration data for PK/ Bioavailability/Bioequivalence studies• Sample Size Calculation for Bioequivalence Studies• SAS Certified Base Programmer for SAS 9 (June 2013)

Experience

1. Senior Principal Statistical Programmer

   Fortrea

   Sep 2024 — Present · Pune, IN

Education

• Savitribai Phule Pune University

  Master of Science (M.Sc.), Statistics

  2004 — 2007

• North Maharashtra University

  Bachelor of Science (B.Sc.), Statistics

  2002 — 2004

Skills

• Data Management
• Sas Programming
• Randomization
• Cluster Analysis
• Microsoft Office
• Biostatistics
• Linear Regression
• Clinical Data Management
• Statistics
• Clinical Trials
• Statistical Programming
• Ich Guidelines
• Cdisc Sdtm and Adam
• Regression Analysis
• Oncology
• Sas Base
• Protocol
• Sample Size Calculation
• Sas
• Pharmacokinetics
• Bioequivalence
• Edc
• Good Clinical Practice (Gcp)
• R
• Gcp
• Winnonlin
• Clinical Study Report
• Ms Office
• Clinical Study Design
• Survival Analysis
• Sas Certified Base Programmer
• CRO
• Statistical Modeling
• Sdtm
• Statistical Analysis Plans
• Time Series Analysis
• Clinical Research
• Cdisc
• Testing of Hypothesis
• Validation