Karan Shah
Statistical Programmer
- Role
- Senior Data Analyst, Rwe at Thermo Fisher Scientific
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Karan Shah
Principal-level Statistical Programming leader with 14+ years of experience supporting Phase 1–3 clinical trials and Real-World Evidence programs in Oncology and Vaccines. Extensive expertise in FDA submissions, REMS regulatory assessments, and CDISC implementation (SDTM, ADaM, Define.XML v2.0). Proven track record of leading cross- functional programming teams, delivering Phase 3 submissions, and building standardized pipelines for multi-study networks. Experienced in portfolio-level oversight, resource planning, regulatory reporting, and mentoring statistical programming teams. Recognized for driving data standardization initiatives and improving programming efficiency across complex global studies.
Experience
Senior Data Analyst, Rwe
Feb 2024 — Present
TA: Oncology, Vaccines• Lead statistical programming strategy and delivery for RWE and FDA-mandated REMS programs.• Oversee development of CDISC-compliant SDTM/ADaM datasets and validated inferential TFLs for regulatorysubmissions.• Serve as programming lead interfacing with epidemiologists, statisticians, regulatory teams, and sponsors.• Provide resource forecasting, bid support, and project tracking across multiple concurrent studies.• Ensure compliance with CDISC standards and internal validation procedures.• Drive methodological implementation for REMS effectiveness and safety evaluations using clinical trial and real-world data.
Education
The Maharaja Sayajirao University of Baroda
MSc, Applied Mathematics (Industrial Mathematics)
University of Mumbai
BSc, Mathematics
University of Washington
Master of Science - MS, APPLIED MATH: APPLIED & COMPUTATIONAL
Skills
- Logistic Regression
- Statistical Modeling
- Sas/Sql
- Regression Testing
- Market Research
- Microsoft Excel
- Matlab
- Business Intelligence
- Analytics
- Biostatistics
- Sas
- Applied Mathematics
- Sas Programming
- Regression
- Business Analytics
- Sql
- Data Mining
- Git
- Biostat
- Statistics
- Data Analysis
- Analysis
- Excel
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