Personal Information
Organization / Workplace
Switzerland Switzerland
Occupation
Director, Clinical Data Standard and Data submission at Cytel Inc
Industry
Medical / Health Care / Pharmaceuticals
About
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...
Tags
cdisc
sdtm
oncology
adam
sas
migration
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
ctcae
See more
- Presentations
- Documents
- Infographics