Ruth Alonso Meseguer

Biostatistician home based: SAPs, TLFs, BDRMs,ADAMs, Statistical analysis report Input in Protocols/CRFs safety poolings SDTM conversions

Descripción Biometrics Head, Local <p>Project Management (all biometrics)<br>Stat analyst ; SAS datasets with macros, creation of SAPs, TLFs, BDRMs, creation of stat reports to sponsors.<br>Account manager: Sales for biometrics department. Biostatistician (International) Stat analyst mainly for phase I studies; SAS datasets with macros, creation of SAPs, TLFs, BDRMs,</p>

Therapeutic area supervisor All Endo-Cardio project coordination (people and project management).- Advisor for CDMCs, Stats, CRPs, Project managers…- Control of Enrolment, randomization ratio, identification of Intent to treat. - Co-coordination with project managers of e-data captured studies.- Data reporting, final review of data

Implementation of phase III and IV department for European studies (observational studies and CTNRs, local and regional).- Project coordination from the early phases (design and development) to data lock and analysis.- Design of data fields in CRFs/DCFs according to CDISC.- Input in Protocols, SAP, final reports, papers, abstracts.-“External expert” within study writing group.-Design databases in SAS .-DBQR (data base quality Review) .-Creation of SOPs and training material for CRPs,CRAs.

CNS validation tasks for Global multi center studies and eight data locks.

300 hours course

260 hours course