Mihir Shelke
Cary,NC
Summary
An analytically driven engineering graduate with 3-5 years of database analysis programming experience, seeking to leverage technical expertise and practical knowledge for a career in clinical trials. Experienced in applying programming skills to studies involving Oncology and Neuroscience, with a focus on data integration and system optimization. Known for delivering high-quality code, innovative solutions, and effective troubleshooting in complex, deadline constrained environments. Recognized for strong communication, collaboration, and a proactive approach to achieving project success. Offers versatility in programming languages and excellent task prioritization skills to meet team and client needs effectively.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Sas Programmer
Highpoint Standards, LLC
12.2022 - 10.2024
- Clinical Trials phases
- Data Reporting from Clinical Trials
- Trial Setup Documents – Protocol, SAP and CRF overview
- Building SDTM/ADaM Specs from CRF/SAP using implementation guides
- Clinical Data Analysis in SAS
- Reporting in Listings, Tables and Figures
- SDTM and ADaM dataset creation using CDISC Standards
- Primary and QC programming to create tables, listings, and graphs (TLFs)
- Proficient in data step /macro programming for reporting and validation
- Knowledge in mapping CRF variables to SDTM and SDTM to ADaM
- Running P21 reports and fix issues for SDTMs/ADaMs
- In depth knowledge in generating reports using procedures including PROC REPORT, PROC TRANSPOSE, PROC FORMAT, PROC SUMMARY, PROC MEANS, PROC FREQ
- Provided computer programming subject matter expertise to project team members
- Performed code refactoring and optimization to improve performance
- Developed strong communication and organizational skills through working on group projects
- Improved software efficiency by creating automated macros
Education
Mechanical Engineering BS -
NC State University
01.2022
Skills
- Speedy Communication
- Microsoft Office Master
- Ability to explain
- Fast Learner
- Team collaboration
- Software validation
- Database management
- AI integration
- Report generation
- Statistical modeling
Certification
- SAS Certified Clinical Trials Programmer Using SAS 9
- SAS Certified Base Programmer for SAS 9
- Microsoft Office Master Certification
Timeline
Clinical Sas Programmer
Highpoint Standards, LLC
12.2022 - 10.2024
- SAS Certified Clinical Trials Programmer Using SAS 9
- SAS Certified Base Programmer for SAS 9
- Microsoft Office Master Certification
Mechanical Engineering BS -
NC State University
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