Personal Information
Organização/Local de trabalho
Switzerland Switzerland
Cargo
Director, Clinical Data Standard and Data submission at Cytel Inc
Setor
Medical / Health Care / Pharmaceuticals
Sobre
I have more than 20 years of experience in the field of Clinical Research in the area of data-management and statistical programming with different roles in Academic Organisation, CRO and Pharmaceutical Industry, in Italy, Switzerland and UK.
I have strong expertise in SAS programming and CDISC standards (mainly SDTM and ADaM).
My core expertise is Oncology from phase I to phase IV; in the past I also had experience in Cardiovascular and Intensive Care therapeutic area. While working for Academic Organisation I had also the possibility to conduct epidemiology studies and systematic review of literature data (meta-analysis).
As head of a data management team I also led the computer sy...
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cdisc
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oncology
adam
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survival analysis
fda
phuse
adaptive design
data submission
statistical programming
reviewer guide
legacy studies
cdsic cfast
therapeutic area
wiki
ad
beginners
meta-analysis
anlysis
clinical study report
stat output
ich guidances
safety
dsur
ich
introduction
endpoints
drug development
recist
efficacy
data submision
interpretation
.net
dose escalation
triage
normalisation
si unit
laboratory data
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