Biostatistician

On behalf of our client - multinational pharma group - Jefferson Wells is looking for a BIOSTATISTICIAN (Pharma or CRO)As Biostatistician specialist you will provide methodological support and ensure the proper management and analysis of the data from the studies on new drugs or marketed drugs by the Group’s companies followed by the CROs or directly including pooling of more studies. You will improve and update the technical know-how about the new statistical methods.
Key Responsibilities:
• Statistical input provided by the group to all major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, summaries of clinical safety and efficacy.
• Analysis the data and evaluation the results from clinical studies or meta-analyses.
• Development of the statistical analysis plan and programming tables in electronic format.
• Performing review for clinical study protocols and statistical/data management documents generated by others.
• Programming in SAS to perform statistical analyses and prepare the output tables and listings.
• Interaction with R&D Quality Assurance Unit in auditing the Contract Research Organizations and study sites.
• Interaction with the Drug Safety Unit to evaluate the data from the pharmacovigilance database (signal detection).
• Interaction with the Medical department functions (CPL, CRA) to prepare and analyze the data from the clinical studies.
• Interaction with the R&D Quality Assurance Unit to guarantee the quality of the analyses conducted on the study data.
•  Close collaboration with Therapeutic Area management in defining strategic approaches to clinical trials and in meeting operational requirements of development plans.
• Attending the Project Teams in order to guarantee the technical support related to the therapeutic area of competence for all the activities foreseen.
• Statistical and data management input in the preparations of scientific publications and study data presentations in public events
• Review of the document/analyses performed by CRO with estimated timelines

Permanent contract (base salry + incentives + benefits)
Based within Milan HQ

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