biostatistician in siena

posted
job type
somministrazione
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job details

posted
location
siena, toscana
job category
Infermieristica, farmacia, medicina
job type
somministrazione
working hours
Full Time
experience
1 anno
reference number
SE201834991
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job description

For a major chemical and pharmaceutical company we are looking for a Biostatistician.
The resource will provide stat expertise to support the different study designs.

skills

University degree in Statistics or Mathematics, preferred PhD in Statistics, Mathematics or Epidemiology; Experience in SAS software and sample size computation for standard designs; Good oral and written communication in English including ability to explain difficult issues and situactions clearly and ensures meaning is understood.
Lingua: Inglese

Conoscenze informatiche: SAS

responsibilities

Key Responsibilities Responsible for a whole study from design to execution for different study designs: -to use stat methodology to establish study strategy (eg power modelling of different scenari, set up power monitoring, set up mitigation plan to minimize risk of stat failure); -to provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis); -to provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation); -to develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review; -to review the TFL, to coordinate review with the stat analyst, to approve the TFL; -to do the QC of the statistical analysis methodology; -to validate study specific dataset & analysis pgm specification; -to approve deviation from TFL format; -to propose SAR conclusion; -to prepare answer to study specific stat question (eg insspection, RA question).

educational requirements

Master universitario o dottorato