Statistical Scientist/Consultant
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Assigned by PRO-UNLIMITED and Catalyst. Responsible at providing support to clinical research teams on outcome research, data science studies, phase IV studies, publications, etc. Clinical therapeutic areas involved several rare diseases including hemophilia and mucopolysaccharidosis (MPS), among others.
Director Biostatistics at BioMarin Pharmaceuticals (2020-07 – 2026-05)
Assigned by PRO-UNLIMITED and Catalyst. Responsible at providing support to clinical research teams on outcome research, data science studies, phase IV studies, publications, etc. Clinical therapeutic areas involved several rare diseases including hemophilia and mucopolysaccharidosis (MPS), among others.
Director Biostatistics at EMD Serono Inc. (2017-08 – 2020-07)
Assigned by PharmStats. Responsible at providing support to data science work for publication and regulatory agency queries, mainly focused on cancer treatments clinical trials data mining and exploration for marketing research. Data handled involved combined therapies and/or immune-therapies such as PD-L1.
Director Biostatistics at BiogenIdec/Biogen (2010-01 – 2017-08)
Assigned by PharmStats. Responsible at leading a group to provide support on publications, investigator initiated studies (IIS), phase IV clinical trials with CDISC/SDTM and ADaM data preparation from raw data, statistical analysis of various models, observational trials annual updates, safety report/DSUR/PSUR. Indications involved multiple sclerosis and hemophilia.
Director Biostatistics at Boehringer-Ingelheim Pharmaceuticals (2007-06 – 2009-12)
Assigned by PharmStats. Responsible at providing support on a large-scale phase III clinical trial on HIV infected patients worked on CDISC/SDTM and AdAM data.
Senior Statistician/Director Biostatistics at Pharm-Olam International (2006-01 – 2008-07)
Assigned by PharmStats. Responsible as a Project Statistician managed several phase II or III regulatory registry clinical trials (for several sponsors) for regulatory submissions. Routine work involved participating in project team meeting with clinicians, medical writers, regulatory consultants, data management, SAS programmers; Writing ADaM data specs; Writing SAP; Overseeing project timelines; Review CSR complying ICH guidance, among other regular statistical related clinical activities.
Senior Statistician at Boehringer-Ingelheim Pharmaceuticals (2003-03 – 2005-12)
Assigned by PharmStats. Responsible at providing statistical programming to a large scale (195 trials) ISS report as well as phase III trials for pain management.
Project Statistician and Principle Project Programmer at PPD Pharmaco (1997-07 – 2003-03)
Assigned by PharmStats. Responsible leading a programmer group supporting clinical reports preparation, regulatory requests, several late phase trials, and one NDA and one ISE submission in pain management. Clinical therapeutic areas involved CNS, pain management, and ED, among others.
Assistant Professor of Mathematics at Texas State University (1991-08 – 1997-07)
PhD in Mathematics – University of Utah (1991-07)