Medi Krupa Samuel
Statistical programmer| SAS Analyst | SDTM , ADaM & TLF | Oncology | SAS (Base 9.4, Macro) | R | MYSQL | Python
- Role
- Machine Learning Data Associate at Amazon
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Medi Krupa Samuel
Experienced Statistical Programmer specializing in Oncology and Immunology therapeutic areas. Expert in SAS 9.4 (Base, Macro, SQL) with advanced proficiency in R (tidyverse, admiral, haven) and Python for data validation and automation.\"Developed 15+ CDISC-compliant SDTM and ADaM datasets across 3 oncology trials, achieving zero critical Pinnacle21 findings in all regulatory submissions, working with SDTM IG 3.2/3.3 and ADaM IG 1.1/1.3 guidelines. Specialized in complex SDTM domains including exposure (EX), concomitant medications with WHO Drug coding (CM), and device datasets (DV), plus advanced ADaM datasets for survival analysis (ADTTE) and recurrent events (ADAETTE).My technical expertise encompasses advanced SAS programming with strong capabilities in data manipulation, validation, and generating outputs in multiple formats including RTF, PDF, and HTML using ODS facilities. I have practical experience working with RAVE studies and Operational Data Model implementations, ensuring seamless data flow and integration.Quality and compliance are central to my approach. I am proficient in creating essential documentation such as Define.xml, mapping specifications, aCRF annotations, SDRG, and ADRG that align with regulatory requirements. My validation skills using Proc Compare and Pinnacle21 ensure data integrity and accuracy across all deliverables.I bring a solid understanding of clinical trial phases (I-IV) and am comfortable working with study-related documents including protocols, SAPs, CRFs, and controlled terminology. As a detail-oriented professional, I am committed to delivering high-quality, timely statistical programming solutions that meet regulatory standards and support critical clinical research objectives.
Experience
Machine Learning Data Associate
Jan 2021 — Present · Hyderabad, IN
Education
Osmania University
Master's degree, Biotechnology, Molecular genetics
Loyola Academy, Hyderabad
Bachelor of Science - BS, Biotechnology
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