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Aditya Patel

@adityapatel1

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Results-driven Biostatistician with expertise in clinical trial design.

United States

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What I'm looking for

I am seeking a role that fosters innovation in clinical research and values collaboration.

I am a results-driven Biostatistician with over 15 years of experience leading biometrics operations, specializing in biostatistics, statistical programming, and clinical data management. My expertise lies in designing and analyzing Phase I-IV clinical trials across various therapeutic areas, including oncology and rare diseases. I have a proven track record of success in regulatory submissions and cross-functional collaboration, ensuring high-quality statistical outputs that support clinical development and regulatory strategies.

Throughout my career, I have implemented innovative study designs and advanced statistical methodologies, such as Bayesian adaptive designs and biomarker-driven analyses. My leadership experience includes managing CROs and collaborating with cross-functional teams to drive data-driven decision-making. I take pride in my ability to communicate complex statistical concepts to non-statisticians, fostering a collaborative environment that advances clinical programs and enhances patient outcomes.

Experience

Work history, roles, and key accomplishments

Current

Associate Director, Biostatistics

Current

Telix Pharmaceuticals

Oct 2023 - Present (1 year 9 months)

Led statistical strategy for Phase III oncology and rare disease trials, overseeing study design, sample size calculations, and protocol development. Applied Bayesian adaptive designs and basket trial methodologies to optimize rare disease studies, ensuring robust statistical power despite small sample sizes.

Bayesian Adaptive Designs Basket Trial Methodologies SAP Development

Principal Biostatistician

Inovio Pharmaceuticals

Nov 2020 - Aug 2023 (2 years 9 months)

Spearheaded statistical tasks for oncology and rare disease trials, including protocol development, SAP creation, and reporting. Designed and analyzed a Phase 1/2 glioblastoma trial, applying Cox Proportional Hazards and Kaplan-Meier methods to assess survival outcomes.

Cox Proportional Hazards Kaplan Meier Umbrella Trials N Of 1 Trials

Principal Biostatistician

Pfizer

Sep 2013 - Nov 2020 (7 years 2 months)

Served as lead statistician for Medical Affairs and Life Cycle Management, overseeing statistical aspects of Phase I/II, III, IIIb, and long-term extension studies in oncology and rare diseases. Designed and analyzed diagnostic test evaluations, including sensitivity/specificity and ROC analyses.

Diagnostic Tests Sensitivity Specificity ROC Analyses SAP Authoring Regulatory Submissions

Senior Biostatistician

Veristat CRO

Jan 2007 - Sep 2013 (6 years 8 months)

Provided statistical consultation and leadership for Phase I-IIIb clinical trials in oncology and rare diseases, overseeing study design, sample size calculations, protocol development, and CRF design. Authored and reviewed SAPs, analysis/dataset specifications, and clinical study reports, contributing to BLA/MAA submissions.

Survival Analysis Cox Proportional Hazards Kaplan Meier Adaptive Trial Designs

Education

Degrees, certifications, and relevant coursework

New Jersey Institute of Technology

Master of Science, Biostatistics

2007 - 2009

Grade: Dean's List

Completed a Master of Science in Biostatistics, focusing on advanced statistical methodologies relevant to clinical trials and data analysis. Achieved Dean's List recognition for academic excellence.

Rutgers University

Bachelor of Science, Biotechnology

2003 - 2007

Grade: Dean's List, Best Academic Performance in Biology and Statistics Departments

Earned a Bachelor of Science in Biotechnology, with a strong emphasis on biological and statistical principles. Recognized for best academic performance in both Biology and Statistics departments, and achieved Dean's List.