Über Fatiha
Helping pharma teams make confident clinical development decisions in complex and high-risk environments.
I am a Biostatistician and Quantitative Decision Scientist with 15 years of consulting experience in the pharmaceutical industry, supporting high-stakes decision-making in clinical development. My academic background provided a strong foundation in statistical and mathematical methods, which I have applied throughout my career to clinical development projects.
I am typically engaged to:
• support dose selection and optimization through exposure-response and longitudinal modeling
• inform go/no-go decisions and development strategies
• strengthen the robustness and interpretability of clinical trial results
• provide strategic input for regulatory submissions and evidence generation
• de-risk development programs through simulation and predictive modeling.
My approach: combining statistical rigor, deep understanding of clinical development, and strategic thinking to maximize the value of data and support critical decision-making.
Available for high-impact consulting assignments requiring senior expertise and strong decision support.
Publications:
1. Rachedi F, Jreich R, Sparks S, et al. Clinical modeling of motor function to predict treatment efficacy and enable in silico treatment comparisons in infantile-onset Pompe disease. CPT Pharmacometrics Syst. Pharmacol. 2024.
2. Rachedi F, Koiwai K, Gaudel-Dedieu N, et al. Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma. CPT Pharmacometrics Syst. Pharmacol. 2022.
3. Fatiha Rachedi, Kimiko Koiwai, Nadia Gaudel-Dedieu, et al. Exposure-Response Analyses and Disease Modeling for Selection and Confirmation of Optimal Dosing Regimen of Isatuximab in Combination Treatment in Patients with Multiple Myeloma. BLOOD 2019.
Englisch
Verhandlungssicher
Französisch
Muttersprachlich oder zweisprachig
Nur remote
Führt Projekte hauptsächlich remote aus
Projekt- und Berufserfahrung
- Sanofi R&DContractor: Clinical Modeling & Simulation BiostatisticianPHARMAZEUTISCHE INDUSTRIENovember 2014 - Juni 2024 (9 Jahre und 7 Monate)Chilly-Mazarin, Frankreich
- Lead for pharmacodynamic Modeling and Simulation (M&S) projects: M&S methodology, design and analysis plan, datasets derivation, M&S and advanced exploratory analysis implementation, report, poster and publication drafting.
- Research in the methodology of dose-response and exposure-response analysis for efficacy and safety endpoints in oncology, immunology …
- Research in the methodology of statistical predictive models' development (linear/non-linear mixed model, survival, logistic…), adaptation and implementation for complex data (population heterogeneity, inclusion criteria impact, simple size limit, inert-intra patients' variability, confounding factors...)
- Simulations of different scenarios (in silico trials for dose and frequency selection, control comparison, benefit/risk optimization, inclusion/exclusion criteria impact)
- Advanced exploratory and confirmatory analysis to support clinical study design and new drug submission (population matching methods using RWD, external control arm, sub-groups identification, inclusion exclusion criteria)
- Model based Meta-analysis
- Surrogate clinical endpoints in oncology
- Advanced exploratory analysis, Supervised and unsupervised mathematical methods to support clinical study design and decision-making using clinical, observational and RWD data (clustering, binary outcome prediction for efficacy and safety data, data dimension reduction, Random Forests, PCA…)
- Software used: SAS, R, Python, Monolix
- Therapeutic areas: Oncology (NSCLC, breast, multiple myeloma), rare disease and rare blood (Pompe disease, …), Immunology and Inflammation (Asthma, spontaneous urticaria, Atopic dermatitis…), type 2 diabetes.
- Collaboration with cross functional teams (clinicians, regulatory, pharmaco-metricians, HEOR or market access stakeholders …)
- Pierre Fabre OncologyContractor: Biostatistician in charge of Ad-hoc analysisPHARMAZEUTISCHE INDUSTRIEJuni 2025 - Dezember 2025 (6 Monate)Boulogne-Billancourt, FrankreichBiostatistician in charge of Ad-hoc analysis and support to FDA submission and EMA post-submission dossier for an allogeneic T-cell immunotherapy treatment.- Ad-hoc statistical analyses using SAS software.- TFLs validation and review documents for CSR, clinical/safety modules update and Safety Update Report (pool data) for EMA reassessment and FDA dossier submission and questions.
- RocheContractor: Modeling and decision-making Biostatistician/Data MinerPHARMAZEUTISCHE INDUSTRIEOktober 2012 - Oktober 2014 (2 Jahre)Boulogne-Billancourt, Frankreich
- Development and implementation of Ad-hoc analysis and predictive models for clinical and observational studies using SAS, R and BayesiaLab.
- Statistical Modeling analysis plan, implementation and validation, presentation and report drafting.
- Drug disease time-dependent progression models.
- Supervised and unsupervised machine learning for patients sub groups identification and patients' inclusion/exclusion criteria optimization (Bayesian networks, cubic classification, Random Forests, PCA…)
- Software used: R, SAS, BayesiaLab and cubic classification.
- Therapeutic areas: Oncology (breast, colon and lung), kidney disease (anemia)
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Ausbildung und Abschlüsse
- PhD applied mathematics in probabilities and statisticsPierre & Marie Curie University2005PhD applied mathematics
Zertifizierungen
- 1. NON-linear Mixed Effects Modeling & PDx-Pop: Intermediate, New and Advanced Features of NONMEM 7ICON2025
- Simulx from simple to complex simulationsSimulations Plus2025