Isabelle Dubois

isabelle.dubois@email.be | +32 2 847 5934 | Rue de la Paix 42, 1050 Brussels | linkedin.com/in/isabelledubois

PROFESSIONAL SUMMARY

Accomplished biostatistics leader with 15+ years of experience driving statistical strategy and execution across clinical development programs in oncology, neuroscience, and cardiovascular therapeutic areas. Proven track record of leading cross-functional teams, advancing drug development from early-phase through regulatory submissions, and building high-performing biostatistics organizations. Expert in adaptive trial designs, biomarker integration, and translational science applications.

PROFESSIONAL EXPERIENCE

Senior Director, Biostatistics
Pharmatech Solutions | Basel, Switzerland | January 2020 – Present

• Lead biostatistics strategy and operations for a portfolio of 12+ clinical programs spanning oncology, Alzheimer's disease, and cardiovascular indications with combined budget exceeding $300M annually
• Direct team of 18 biostatisticians and programmers supporting Phase I-III trials, providing mentorship and technical oversight on complex statistical methodologies
• Collaborate with Clinical Development, Regulatory Affairs, and Data Sciences to design innovative adaptive trials incorporating predictive biomarkers, reducing development timelines by 18 months
• Serve as statistical lead for two successful IND submissions and one NDA filing in rare oncology indications
• Establish statistical standards and SOPs aligned with ICH guidelines, improving audit readiness scores by 35%

Director, Biostatistics
Novalis Therapeutics | Amsterdam, Netherlands | June 2016 – December 2019

• Managed biostatistics support for oncology and pediatric clinical programs across 8 global trials with 2,500+ patients enrolled
• Designed statistical analysis plans for pivotal Phase III trials in solid tumors, incorporating novel endpoints and biomarker-driven subgroup analyses
• Led statistical contributions to regulatory interactions with FDA and EMA, resulting in accelerated approval pathway designation for two assets
• Built and mentored team of 9 biostatisticians, implementing competency development framework that reduced turnover by 40%
• Partnered with translational science teams to integrate genomic and proteomic biomarkers into clinical trial designs

Senior Principal Statistician
Oncogen Biosciences | Brussels, Belgium | March 2013 – May 2016

• Served as lead statistician for 5 Phase II/III oncology trials, overseeing protocol development, randomization, interim analyses, and final reporting
• Developed Bayesian adaptive designs for early-phase oncology studies, optimizing dose-finding and patient allocation strategies
• Contributed statistical expertise to cross-functional leadership teams for two major drug development programs in immuno-oncology
• Authored statistical sections of regulatory submissions, clinical study reports, and peer-reviewed publications (15+ manuscripts)
• Provided statistical consultation on biomarker validation studies and companion diagnostic development

Principal Statistician
Medstat Europe | Antwerp, Belgium | August 2009 – February 2013

• Designed and analyzed Phase I-II clinical trials in cardiovascular disease and metabolic disorders
• Implemented innovative statistical methods for longitudinal data analysis and missing data handling in clinical trials
• Collaborated with Data Management and Clinical Operations to ensure data quality and protocol compliance
• Supported regulatory submissions including responses to FDA information requests and advisory committee briefing materials

Statistician
Clinical Analytics Group | Ghent, Belgium | July 2007 – July 2009

• Conducted statistical analyses for early-phase clinical trials in oncology and neurology
• Developed SAS programs for efficacy and safety analyses, tables, listings, and figures
• Participated in protocol development and statistical analysis plan writing for multiple studies

EDUCATION

Ph.D., Biostatistics
Université Libre de Bruxelles | Brussels, Belgium | 2007
Dissertation: Adaptive Methods for Clinical Trials with Time-to-Event Endpoints

M.S., Statistics
KU Leuven | Leuven, Belgium | 2003

B.S., Mathematics with Biology Minor
Ghent University | Ghent, Belgium | 2001

TECHNICAL SKILLS

Statistical Methods: Clinical trial design, adaptive designs, survival analysis, longitudinal data analysis, Bayesian methods, missing data imputation, multiplicity adjustment, biomarker analysis

Software: SAS, R, NONMEM, WinBUGS, EAST, nQuery

Therapeutic Areas: Oncology, Alzheimer's disease, cardiovascular disease, pediatrics, rare diseases

Regulatory: ICH guidelines (E3, E9, E9-R1), FDA/EMA interactions, IND/NDA submissions

SELECTED PUBLICATIONS

• Dubois, Isabelle, et al. "Biomarker-driven adaptive trial designs in precision oncology." Clinical Trials Journal, 2022.
• Dubois, Isabelle, et al. "Statistical considerations for Alzheimer's disease trials with cognitive endpoints." Neurology Research, 2021.
• Dubois, Isabelle, et al. "Bayesian methods for early-phase dose-finding in oncology." Statistics in Medicine, 2019.

PROFESSIONAL AFFILIATIONS

• American Statistical Association (ASA) – Member
• Society for Clinical Trials (SCT) – Member
• Biopharmaceutical Section of ASA – Member
• Statistical Programmers and Analysts Special Interest Group (SPASIG) – Member

LEADERSHIP & MENTORING

• Mentor for 6 junior biostatisticians through company mentorship program
• Speaker at industry conferences on adaptive trial designs and biomarker integration
• Member of company-wide Statistics Leadership Council