Umesh Kumar
Clinical and Statistical Programming Expert | Global Head of Digital Healthcare & Biostatistics Innovation
- Role
- Associate Stat Programming Director at IQVIA India
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Umesh Kumar
Pioneering Clinical and Statistical Programmer with over 15 years of transformative…
Experience
Associate Stat Programming Director
May 2017 — Present · Pune, IN
Responsible for executing high-quality clinical programming, adhering to CDISC guidelines, utilizing SDLC principles, mentoring programmers, collaborating with statistical teams, and creating specifications, data presentations, and validation plans to support clinical trial deliverables. Transformed Clinical Programming Workflows: Revolutionized the sector by automating workflows using tools like the Study Metadata Thread (SMT) Tool, improving study-level metadata consistency, traceability, and reducing human error. Advancing Data Integrity and Compliance: Automated critical processes like log file quality checks and RTF to SAS dataset conversions, enhancing data validation accuracy, speeding up project timelines, setting industry benchmarks for quality and reliability. Catalyst for FDA-Approved Innovations: Played a pivotal role in regulatory success, optimizing clinical data management using SAS, R, and Python, contributing to multiple FDA-approved medications. Pioneering Contributions Recognized: Awarded Innovator of the Year for groundbreaking advancements in clinical programming, automating data audits, and setting new standards for raw data conversion into standardized formats, significantly advancing the clinical research sector.
Skills
- CRO
- Sas Base
- Ich-Gcp
- Clinical Data Management
- C
- Oracle Clinical
- Sas Programming
- Xml
- Gcp
- Good Clinical Practice (Gcp)
- Clinical Trials
- Statistical Programming
- Validation
- Clinical Research
- Data Integration
- Cdisc
- Biostatistics
- Sdtm
- Edc
- Crf Design
- Data Management
- Sas
- CRO Management
- Statistics
- Perl
- 21 Cfr Part 11
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