Rachel Bennett

• Phone: +353 87 123 4567
• Email: rachel.bennett@email.com
• Location: Dublin, Ireland
• LinkedIn: rachelbennettbiostat

Summary

Leveraging 7 years of experience in biostatistics, I have successfully designed and analyzed complex clinical trials across various therapeutic areas, consistently delivering high-quality statistical reports. My contributions have directly supported regulatory submissions and informed critical drug development decisions for pharmaceutical and biotechnology firms.

Adept at applying advanced statistical methodologies, including survival analysis, mixed models, and Bayesian approaches, to extract meaningful insights from large-scale biomedical datasets. Proven ability to collaborate effectively with cross-functional teams, translating complex statistical concepts into actionable recommendations for clinical and research stakeholders.

Experience

Senior Biostatistician, Pharmatech Ireland -- Dublin, Ireland

Mar 2020 – present

• Led the statistical design and analysis for 5 Phase III clinical trials in oncology and immunology, contributing to 2 successful regulatory submissions to the EMA.

• Developed and validated statistical programming code in R and SAS, ensuring 100% accuracy and compliance with ICH-GCP guidelines for all assigned studies.

• Provided expert statistical consultation to clinical development teams, influencing study protocols and data collection strategies to optimize statistical power and efficiency.

• Mentored junior biostatisticians, enhancing team capabilities in statistical programming, study design, and report generation.

Biostatistician, BioMetrics Research -- Dublin, Ireland

June 2017 – Feb 2020

• Performed statistical analysis for Phase I and II clinical trials, including pharmacokinetic/pharmacodynamic (PK/PD) modeling and dose-response analyses.

• Contributed to the development of Statistical Analysis Plans (SAPs) for over 15 studies, ensuring alignment with study objectives and regulatory requirements.

• Generated tables, listings, and figures (TLFs) using SAS for clinical study reports, reducing report generation time by 15% through automation scripts.

• Collaborated with data management teams to ensure data quality and integrity, resolving data discrepancies efficiently.

Education

University College Dublin, MSc in MSc in Biostatistics -- Dublin, Ireland

Sept 2015 – June 2017

National University of Ireland Galway, BSc in BSc in Mathematical Science -- Galway, Ireland

Sept 2012 – June 2015

Skills

Statistical Software: SAS (Base, STAT, Macro), R (ggplot2, dplyr, lme4, survival), Python (Pandas, NumPy, SciPy), WinBUGS, nQuery

Statistical Methodologies: Clinical Trial Design (Adaptive, Crossover, Parallel), Survival Analysis, Mixed Models, Bayesian Statistics, Regression Analysis, Non-parametric Methods, Power and Sample Size Calculation, PK/PD Modeling

Regulatory & Guidelines: ICH-GCP, EMA Guidelines, FDA Regulations, CDISC (SDTM, ADaM)

Data Management & Visualization: SQL, Data Cleaning, Data Imputation, Tableau, Microsoft Excel

Communication & Collaboration: Technical Writing, Presentation Skills, Cross-functional Team Leadership, Mentoring