Biostatistician

2 settimane fa

Lazio, Italia Recordati A tempo pieno

Biostatistician Join to apply for the Biostatistician role at Recordati.Job PurposeWe 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 ResponsibilitiesYou 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 EducationStatistical degree (Statistics, Mathematics)Required Skills And Experience3-5 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 CompetenciesYou have knowledge of GCP and preferably CDISC standards.You know programming in SAS System.Required Behaviours And CompetenciesYou are collaborative, good communicator and able to interact with all levels of the organization.Required LanguagesFluent in English.Equal Opportunity EmployerWe are proud to be an equal opportunity employer.We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical ManufacturingLocationMilan, Lombardy, Italy#J-*****-Ljbffr

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