Ilinca Schmitt Email & Phone Number

North Rhine-Westphalia, Germany

Wuppertal, Nordrhein-Westfalen, Deutschland

Responsible for statistical support of the entire chemical and pharmaceutical development portfolio, from early to late development; driver of the internal statistical training portfolio, including Design and Analysis of Experiments (DoE) and Six Sigma for the Greenbelt certification, etc. backed up by long experience as trainer in statistics and data fundementals for customers with different backgrounds; long working experience on optimization of processes/products and design space… Show more Responsible for statistical support of the entire chemical and pharmaceutical development portfolio, from early to late development; driver of the internal statistical training portfolio, including Design and Analysis of Experiments (DoE) and Six Sigma for the Greenbelt certification, etc. backed up by long experience as trainer in statistics and data fundementals for customers with different backgrounds; long working experience on optimization of processes/products and design space justification by sound statistical rationales in the QbD frame for preparation of technical submission documentation, from small to large molecules, from parenteral to solid formulations. As a passionate data professional, worked two years as project lead of a block-buster digitalization project, which documented the status-quo of the (big) data landscape along the whole product development chain and provided valuable insights in the data quality and infrastructure gaps, triggering further digitalization initiatives of the digital road and paving the way to artificial intelligence applications. Successfully supported the implementation of R&D digital fluency trainings with FAIR and metadata expertise and other data oriented initiatives. Show less

Leverkusen, North Rhine-Westphalia, Germany

On-project support of Applied Mathematics with building Machine Learning classification algorithms for diagnostic purposes in R and Python, Big Data engineering, Data Visualization, dealing with internal and external medical customers, data presentation, refreshing and updating machine learning knowledge.

Wuppertal, North Rhine-Westphalia, Germany

Statistical Consulting on CMC statistical topics for chemical, analytical, formulation, biological development, product supply, quality, animal health; focus on statistical planning and analysis of experiments (DoE for QbD impementation support), statistical modeling for stability, data mining (production troubleshooting), statistical inference for analytical development, chemometrics (PCA, PLS for spectral data), regular DoE and basic statistics trainings and technical reporting.

Wuppertal, North Rhine-Westphalia, Germany

Oversight of statistical programming and analysis for outsourced activities at the responsible CRO, oversight medical writing for CSP and CSR reports, code validation, drived structure improvement (complexity reduction) and further development of the statistical programming codes, provided statistical consulting to KOLs for scientific publications and to medical experts and project managers.

Wuppertal, North Rhine-Westphalia, Germany

Responsible statistician for single or integrated multi-center clinical study deliverables in many different therapeutical areas (recognized high flexibility in switching between cardiovascular, oftalmology, women health, diabetics and phase II-IV studies), experienced in Clinical Statistics, Meta-Analysis, Clinical Study Planning (Clinical Study Report input, SAP, mock TLFs), playing in international inter-disciplinary teams, oversight of programming activities and submission deliverables… Show more Responsible statistician for single or integrated multi-center clinical study deliverables in many different therapeutical areas (recognized high flexibility in switching between cardiovascular, oftalmology, women health, diabetics and phase II-IV studies), experienced in Clinical Statistics, Meta-Analysis, Clinical Study Planning (Clinical Study Report input, SAP, mock TLFs), playing in international inter-disciplinary teams, oversight of programming activities and submission deliverables preparation on-time (management of timeline and resources), submission support (CSR, TLFs, SAS and R programming, statistical data analysis, risk-benefit assessement, technical reporting, coaching for younger statisticians and students), Bayesian statistics, mixed treatment comparisons (WinBugs), etc. Show less

Almere, Flevoland, Netherlands

My first job in Clinical Statistics by the Biomedical Data Sciences and Informatics at Genzyme, in the Netherlands. Lead statistician on European side for several clinical trials across all phases of clinical development and many therapeutic areas (hematology, biosurgery-medical device, oncology, pediatric, endocrinology); coordination of programming activities, interaction with medical experts and data management, learning about GCP, CDISC, STDMs, ADAMs, writing risk-analysis modules in SAS… Show more My first job in Clinical Statistics by the Biomedical Data Sciences and Informatics at Genzyme, in the Netherlands. Lead statistician on European side for several clinical trials across all phases of clinical development and many therapeutic areas (hematology, biosurgery-medical device, oncology, pediatric, endocrinology); coordination of programming activities, interaction with medical experts and data management, learning about GCP, CDISC, STDMs, ADAMs, writing risk-analysis modules in SAS, SAPs and mock TLFs, technical reporting, input to CSP and CSR for submission, working on transatlantic interdisciplinary teams, methodical exchange sessions, leadership in a project of oncological product transfer between Genzyme and Bayer Schering, building/expending expertise in adaptive designs, multiplicity testing. Show less

Penzberg, Bavaria, Germany

Experienced in application and further development of classification algorithms for early identification of complex diseases (rheumatoid arthritis, colon rectum carcinome) by means of biomarker combinations, knowleadgeable of biomarker data (review of raw data - hundreds of patient's diagnostic case reports on plausibility and completeness), implementation of a comprehensive SAS Macros library (SAS base and IML) for optimization and feature selection in regularized discriminant analysis that… Show more Experienced in application and further development of classification algorithms for early identification of complex diseases (rheumatoid arthritis, colon rectum carcinome) by means of biomarker combinations, knowleadgeable of biomarker data (review of raw data - hundreds of patient's diagnostic case reports on plausibility and completeness), implementation of a comprehensive SAS Macros library (SAS base and IML) for optimization and feature selection in regularized discriminant analysis that immediately helped in filling a knowledge gap in the biometrics department and became the tool to use in development of diagnostic rules based on biomarker combinations; conduction of computer simulation studies, benchmarking of machine learning algorithms (tree methods, discriminant analysis, neural networks), coaching of internships and peers, holding SAS and R trainings for biometrics colleagues, working with data visualization techniques, exploratory analysis and data mining tools, performing scientific research and writing. Show less

Phd, Biostatistics

Dipl. Stat., Biostatistics

Master'S Degree, Mathematics, Informatics