Versatile statistician with an extended experience in clinical (according to FDA and EMA requirement) , preclinical and drug-discovery research, in addition to vast teaching experience in academia and industry. Current position: Senior Director of Clinical Research and Biostatistics in Quark Pharmaceuticals LTD.Clinical experienceLed the clinical development strategy from IND submission to NDA - phase I II & III. Highly involved in the correspondence with FDA on all statistics related issues in clinical development plans, which are all assembled into the SAP (Statistical Analysis Plan) manuscript. Acquired a vast experience in the design of complex innovative clinical trials with cutting edge statistical methodologies, such as sample size re-estimation for complex study endpoints, adaptive and sequential design. Assimilation of statistical methodologies into the working environment, including the use of “esitmands” language in the organization day to day work. Experience in implementation of rigorous statistical methods for the handling and analyses of clinical trial with missing data.Pre-clinicalLed the experiments design, monitoring, analysis and documentation of in-silico, in-vitro and in-vivo studies.Developed an In-vivo data base that handles all the company in-vivo studies design, stores all data obtained in the experiment, including general animal information, and allows querying and monitoring the data in a simple manner. Developed algorithms for analysis: High-through-put screening qPCR, ELISA and Microarray studies, which were implemented in interactive databases. Management skills Led a team of senior statisticians. Coordinated and integrated different disciplines (Statistics, physicians, biologists, project managers, programmers) for clear communication across the company.Managed, recruited, and supervised contract research organizations (CROs): statistical programmers; data managers.
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Director Of BiostatisticsPluriIsrael -
Senior Director Of Clinical Research And Biostatistics, Statistics UnitQuark Pharmaceuticals Jan 2018 - PresentLed the clinical development strategy from IND submission to NDA - phase I II & III. Highly involved in the correspondence with FDA on all statistics related issues in clinical development plans, which are all assembled into the SAP (Statistical Analysis Plan) manuscript. Acquired a vast experience in the design of complex innovative clinical trials with cutting edge statistical methodologies, such as sample size re-estimation for complex study endpoints, adaptive and sequential designs. Assimilation of statistical methodologies into the working environment, including the use of “Esitmands” language in the organization day to day work. Experience in implementation of rigorous statistical methods for the handling and analyses of clinical trial with missing data -
Director Of Clinical Research And Biostatistics, Statistics UnitQuark Pharmaceuticals Jan 2010 - Jan 2018In addition to the above responsibility, created a data monitor infrastructure for ongoing studies in a blinded manner, that had an impact on the company strategies and proved to yield a successful phase II study. The infrastructure also contained a patients’ profile electronic report that has assisted the medical team with their periodic follow up on the patient’s safety. -
Head Of Statistics UnitQuark Pharmaceuticals Mar 2001 - Jan 2010Led the experiments design, monitoring, analysis and documentation of in-silico, in-vitro and in-vivo studies. In Silico: Creating a siRNA activity predictor model, that has become the core algorithm of the company. The model used AI/ML concepts (training and validation sets), clustering methods such Principal Component Analysis (PCA) and Stepwise regression. In-vitro: Developed algorithms for analysis: High-through-put screening qPCR, ELISA and Microarray studies, which were implemented in interactive databases.In-vivo: Developed an In-vivo data base that handles all the company in-vivo studies design, stores all data obtained in the experiment, including general animal information, that has allowed querying and monitoring the data in a simple manner. -
Operation Research EngineerIai - Israel Aerospace Industries Mar 1999 - Mar 2001Development of algorithms and testing them via computerized simulations, using Fortran and Matlab tools. -
Guest ScientistForschungszentrum Jülich Aug 1997 - Aug 1998Jülich, North Rhine-Westphalia, GermanyGame theory - Inspection games -
InstructorThe Hebrew University Of Jerusalem Sep 1991 - Sep 1996Jerusalem, Israel1991 - 1996 - Department of Statistics, Hebrew University, Jerusalem, IsraelInstructorTaught Graduate and Undergraduate courses. Selected by the students as Best Instructor of Statistics Department in the year 1995. -
Teaching AssistantThe Hebrew University Of Jerusalem Sep 1986 - Sep 1996Jerusalem, Israel1986 - 1996, Department of Statistics, Hebrew University, Jerusalem, IsraelTeaching AssistantTaught Graduate and Undergraduate courses. -
Research AssistantThe Hebrew University Of Jerusalem Sep 1987 - Sep 1989Jerusalem, Israel1987 - 1989, Department of Zoology, Hebrew University, Jerusalem, IsraelStatistics Research Assistant
Daniel Rothenstein Education Details
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Statistics -
Cum Laude -
Statistics And Economics
Frequently Asked Questions about Daniel Rothenstein
What company does Daniel Rothenstein work for?
Daniel Rothenstein works for Pluri
What is Daniel Rothenstein's role at the current company?
Daniel Rothenstein's current role is Director of Biostatistics.
What schools did Daniel Rothenstein attend?
Daniel Rothenstein attended The Hebrew University Of Jerusalem, The Hebrew University Of Jerusalem, The Hebrew University Of Jerusalem.
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Daniel Rothenstein
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