Gelareh Rahimi
Biostatistician
Plano,TX
Summary
Experienced Biostatistician with over six years of expertise in statistical analysis, clinical trials, and regulatory compliance. Proven leadership in mentoring biostatisticians and managing complex cardiovascular and medical device studies. Extensive knowledge of advanced statistical methodologies, CDISC standards, and SAS programming. Skilled in client interactions, FDA communications, and project oversight to drive clinical trial success.
Overview
6
6
years of professional experience
14
14
years of post-secondary education
Work History
Biostatistician
Spectral AI
01.2023 - Current
- Lead statistical analysis plans for regulatory submissions, including FDA interactions for medical device approval
- Collaborate with multidisciplinary teams, ensuring CDISC-compliant datasets (SDTM, ADaM) for clinical trial reports
- Oversee project financials, including budget preparation, scheduling, and monitoring, ensuring cost-effective execution
- Mentor biostatisticians in SAS Base and SAS Stat programming for complex analyses
Research Scientist II
Amazon Inc.
10.2022 - 01.2023
- Developed NLP models for knowledge discovery
Senior Biostatistician
Baylor Scott & White Health Hospital
07.2019 - 10.2022
- Conducted statistical analysis for cardiovascular studies, including CABG, TAVR, SAVR, and lipid-lowering therapies
- Applied multiple imputation methods to address missing data and ensure robust and reliable clinical trial results
- Implemented adaptive design methodologies to optimize clinical trial efficiency and resource allocation
- Collaborated with Amgen and AstraZeneca on funded research projects to address mutual clinical objectives
- Provided leadership and mentorship to biostatisticians, supporting career development and skill-building
- Utilized CDISC standards to prepare clinical trial datasets and reports, ensuring regulatory compliance
- Engaged in proposal writing and client presentations to support funding acquisition and study alignment
Biostatistician
Carle Foundation Hospital
08.2018 - 07.2019
- Mentored junior biostatisticians in statistical methodologies and SAS programming
- Conducted statistical analyses for multi-disciplinary research projects, including clinical and observational studies
- Prepared statistical reports and contributed to study designs for institutional and external collaborations
Education
PhD - Biostatistics
University of South Carolina
01.2013 - 01.2018
Master of Science - Biostatistics
Shahid Beheshti University of Medical Sciences
01.2008 - 01.2011
Bachelor of Science - Statistics
Shahid Beheshti University
01.2002 - 01.2008
Skills
- Advanced Statistical Methodologies: Multiple Imputation, Adaptive Design, Bayesian Analysis
- Clinical Trial Standards: CDISC SDTM, ADaM
- Regulatory Compliance: FDA Interactions, GCP, ICH Guidelines
- Programming: SAS Base, SAS Stat, R
- Leadership: Team Mentorship, Resource Coordination
- Communication: Client Presentations, Proposal Writing
Timeline
Biostatistician
Spectral AI
01.2023 - Current
Research Scientist II
Amazon Inc.
10.2022 - 01.2023
Senior Biostatistician
Baylor Scott & White Health Hospital
07.2019 - 10.2022
Biostatistician
Carle Foundation Hospital
08.2018 - 07.2019
PhD - Biostatistics
University of South Carolina
01.2013 - 01.2018
Master of Science - Biostatistics
Shahid Beheshti University of Medical Sciences
01.2008 - 01.2011
Bachelor of Science - Statistics
Shahid Beheshti University
01.2002 - 01.2008
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