プロフィール詳細

プロジェクトを作成

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Irene S.に依頼

Netherlands

Senior Biostatistician & Epidemiologist — Clinical-Trial, RWD & HTA Expert

プロフィール概要

Irene Santi is a highly qualified and experienced biostatistician and epidemiologist with a deep expertise in the analysis of both clinical trial data and real-world data (RWD). With over two decades of experience, Irene has worked on numerous projects, providing high-level statistical support and insights for clients in the healthcare and medical technology sectors. Her expertise includes the management and analysis of complex datasets, including registry data, to evaluate treatment pathways, resource utilization, and outcomes in real-world settings. Irene is particularly skilled in applying advanced statistical methodologies to clinical trial assessments, comparative effectiveness research, and health technology assessments, ensuring that study designs and methodologies meet regulatory standards and industry best practices. Proficient in SAS, R, and STATA, she is adept at delivering high-quality, actionable insights that inform healthcare decision-making. As a freelancer, Irene collaborates with clients to bridge the gap between clinical trial results and practical healthcare applications, offering tailored solutions for each project.

専門分野

• ★ Medical Statistics
• ★ SAS
• ★ R
• ☆ Biostatistics
• ☆ Statistics
• ☆ Applied Statistics
• ☆ Excel
• ☆ STATA
• ☆ Clinical Trials
• ☆ Clinical Trials Data Analysis
• ☆ Oncology
• ☆ Radiation Therapy
• ☆ Chemotherapy
• ☆ Surgical Oncology
• ☆ Hematology-Oncology
• ☆ Health Technology Assessment
• ☆ Neuro-Oncology
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Health Economics

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, General Proofreading & Editing

Research Feasibility Study, Gap Analysis, Gray Literature Search, Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Predictive Modeling, Statistical Analysis, Data Visualization, Data Cleaning, Data Insights

職務経験

Consultant/Owner

SantInsights

3月 2023 - 現在

SantInsights

3月 2023 - 現在

Senior Researcher - Statistician

Erasmus University Rotterdam

4月 2020 - 2月 2023

Senior Statistician

Kiadis Pharma

3月 2019 - 2月 2020

Senior Consultant, Statistician

PAREXEL

11月 2017 - 1月 2019

Consultant, Statistician

PAREXEL

12月 2015 - 10月 2017

Medical Statistician

AO Foundation

2月 2014 - 6月 2015

Researcher

Ruprecht Karls Universität Heidelberg

3月 2011 - 3月 2014

Researcher

DKFZ

2月 2009 - 2月 2011

Researcher

Ospedale Policlinico San Martino

12月 2004 - 1月 2009

学歴

PhD

University of Heidelberg

2月 2011 - 4月 2014

Post Graduate Specialization in Biostatistics

University of Pavia

1月 2005 - 1月 2008

MS in Biology

University of Genova

1月 1997 - 1月 2002

認定資格

• NA

  NA

  1月 2025 - 1月 2025

出版物

JOURNAL ARTICLE

Irene Santi, Heleen Vellekoop, Matthijs M Versteegh, Simone A Huygens, Winand N. M. Dinjens, Maureen Rutten-van Mölken (2024). Estimating the Prognostic Value of the NTRK Fusion Biomarker for Comparative Effectiveness Research in The Netherlands . Molecular Diagnosis & Therapy.

Irene Santi, Andrew J. Lloyd, Claudia E. Hastedt, Matthijs M. Versteegh (2023). Societal Utilities for Cognitive Impairment in Schizophrenia: Developing a Preference-Based Scoring Algorithm Based on the Schizophrenia Cognition Rating Scale . Advances in Therapy.

Irene Santi, Saskia de Groot, Pieter Bakx, Bram Wouterse, Pieter van Baal(2023). Informal Care Costs According to Age and Proximity to Death to Support Cost-Effectiveness Analyses . PharmacoEconomics. Springer Science and Business Media {LLC}

Irene Santi, Simone Huygens, Heleen Vellekoop, Matthijs Versteegh, László Szilberhorn, Tamás Zelei, Balázs Nagy, Apostolos Tsiachristas, Rositsa Koleva-Kolarova, Sarah Wordsworth, et al.(2023). Cost-Effectiveness Analysis of Treating Patients With NTRK-Positive Cancer With the Histology-Independent Therapy Entrectinib . Value in Health. 26. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 193--203. Elsevier {BV}

Irene Santi, Ayesha Sajjad, Matthijs M. Versteegh, Jan Busschbach, Judit Simon, Leona Hakkaart-van Roijen(2023). In search of a ‘pan-European value set’; application for EQ-5D-3L . BMC Medical Research Methodology. 23. (1). Springer Science and Business Media {LLC}

(2020). ATIR101 administered after T-cell-depleted haploidentical HSCT reduces NRM and improves overall survival in acute leukemia . Leukemia.

(2019). DNA methylation at an enhancer of the three prime repair exonuclease 2 gene (TREX2) is linked to gene expression and survival in laryngeal cancer . Clinical epigenetics.

(2016). Autologous bone graft in the treatment of post-traumatic bone defects: a systematic review and meta-analysis . BMC musculoskeletal disorders.

(2016). Lifestyle factors and risk of leukemia and non-Hodgkin's lymphoma: a case-control study . Cancer causes & control : CCC.

(2015). Chronic diseases, medical history and familial cancer, and risk of leukemia and non-Hodgkin's lymphoma in an adult population: a case-control study . Cancer causes & control : CCC.

(2014). Risk of leukaemia and residential exposure to air pollution in an industrial area in Northern Italy: a case-control study . International journal of environmental health research.

(2013). Occupation and educational inequalities in laryngeal cancer: the use of a job index . BMC public health.

(2013). To what degree is the association between educational inequality and laryngeal cancer explained by smoking, alcohol consumption, and occupational exposure? . Scandinavian journal of work, environment & health.

(2012). Infectious diseases and risk of leukemia and non-Hodgkin's lymphoma: a case-control study . Leukemia research.

Irene Santi, Kari Hemminki, Marianne Weires, Hauke Thomsen, Jan Sundquist, Justo Lorenzo Bermejo(2010). Tumor location and patient characteristics of colon and rectal adenocarcinomas in relation to survival and TNM classes . BMC Cancer. 10. (1). Springer Science and Business Media {LLC}

(2010). What is the major prognostic factor in tumor-node-metastasis staging of pancreatic adenocarcinoma? . Annals of surgical oncology.