Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting a Clinical Programmer

The Clinical Programmer will join the Clinical Science department of the R&D organization of the company in Florence.
The purpose of the Clinical Programmer is to actively contribute to the development of data analysis plans in collaboration with statistical colleagues, physicians, clinical research scientists, and/or medical colleagues.

MAIN ACTIVITIES AND RESPONSIBILITIES
The resource will report to the Biostatistics Manager, being responsible for all statistical programming tasks on the assigned clinical trials, and performing these tasks with total independence.
• programming ADaM datasets and respective specifications
• programming TLFs according to the SAP
• contribute in any programming necessary for post-hoc analyses, safety analyses or interim analyses
• Participate in the review of Case Report Forms (design phase), Statistical Analysis Plans, QC Specifications and Database Structures
• developing and validating standard SAS macro for SDTM/ADaM programming as well as Tables and Reporting according to computational methods
• supervision of programming activities assigned to CRO
• provide precise indications for the design of the eCRF, IRT, ePRO and review the related technical specifications
• collaborating with Study Statistician in developing the statistical analyses for a study

JOB REQUIREMENTS

• Experience of at least 1 year in the role of biostatistician/programmer in clinical research (company or CRO) is required, with particular reference to phase I-III registration studies in oncology area
• Biostatistics/Mathematics master's degree is preferred
• Fluency in English is required (level C2)
• The necessary technical knowledge are:
• advanced SAS programming
• detailed knowledge of CDISC standards (i.e .: SDTM, ADAM)
• knowledge of the main guidelines (EMA / FDA)

• The technical knowledge appreciated are: eCRF design, R programming, other programming languages, SAS Visual Analytics   

Contract type: fixed term 12 months
 

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