Biostatistician Bardi

Biostatistician
Bardi
Emilia Romagna, Bardi

On behalf of our client - a multinational pharma group - Jefferson Wells is looking for a BIOSTATISTICIAN (Pharma or CRO). As a 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: Provide statistical input for all major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, and summaries of clinical safety and efficacy. Analyze data and evaluate results from clinical studies or meta-analyses. Develop statistical analysis plans and program tables in electronic format. Review clinical study protocols and statistical/data management documents generated by others. Program in SAS to perform statistical analyses and prepare output tables and listings. Interact with the R&D Quality Assurance Unit in auditing the Contract Research Organizations and study sites. Collaborate with the Drug Safety Unit to evaluate data from the pharmacovigilance database (signal detection). Work with Medical department functions (CPL, CRA) to prepare and analyze data from clinical studies. Collaborate with the R&D Quality Assurance Unit to ensure the quality of analyses conducted on study data. Work closely with Therapeutic Area management to define strategic approaches to clinical trials and meet operational requirements of development plans. Attend Project Teams to provide technical support related to the therapeutic area of competence for all planned activities. Provide statistical and data management input in the preparation of scientific publications and study data presentations at public events. Review documents/analyses performed by CRO with estimated timelines. Permanent contract (base salary incentives benefits) Based within Milan HQ J-18808-Ljbffr