Biostatistician

1 settimana fa

Milano, Lombardia, Italia Recordati A tempo pieno
Job Purpose

We are looking for a Biostatistician that 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. The person will improve and update the technical know-how about the new statistical methods.

Key Responsibilities


•    You will close collaborate with the Therapeutic Area management in defining strategic approaches to clinical trials and in meeting operational requirements of development plans.

•    You will be part of the Project Teams in order to guarantee the technical support related to the therapeutic area of competence for all the activities foreseen.

•    You will be in charge of the preparation of the statistical input provided to all major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, summaries of clinical safety and efficacy, as well as in the preparations of scientific publications and study data presentations in public events, and interact with the Medical Writer Unit in their finalization.

•    You will develop or supervise the preparation of the statistical analysis plan and the programming of the output (tables, figures and listings) in electronic format.

•    You will perform the review of the clinical study protocols and statistical/data management documents generated by others.

•    You will analyze the data and evaluate the results from clinical studies or meta-analyses.

•    You will program in SAS to perform statistical analyses and prepare the output tables and listings.

•    You will Interact with the Medical department functions (CPL, CRA) to prepare and analyze the data from the clinical studies.

•    You will Interact with R&D Quality Assurance Unit in auditing the Contract Research Organizations and study sites and to guarantee the quality of the analyses conducted on the study data.

•    You will Interact with the Drug Safety Unit to evaluate the data from the pharmacovigilance database (signal detection).

•    You will lead efforts in the development, maintenance and adherence to divisional SOPs and guidelines.

•    You will review  and oversight  the document/analyses performed by CRO with estimated timelines.

Required Education

Statistical degree (Statistics, Mathematics) 

Required Skills and Experience

3-5 years of experience in a CRO or pharmaceutical company and clinical trials.
You have a clear understanding of theoretical and applied statistic and regulatory guidelines in a pharmaceutical research setting; you are expert in the development and submission of NDA

Technical Competencies

You have knowledge of GCP and preferably CDISC standards.
You know programming in SAS System.

Required Behaviours and Competencies

You are collaborative, good communicator and able to interact with all levels of the organization

Required Languages

Fluent in English


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