Senior Clinical Statistician (m/f)

REFERENZNUMMER:

315296/11

IHRE AUFGABEN:

-You will develop and maintain timely, scientifically sound, innovative and business-oriented plan for the statistical analysis and data management of clinical studies (data management for Umbrella only)
-You will develop, execute or supervise appropriate statistical analyses of clinical trial data
-You will participate in the design and analysis of clinical studies
-You will interact on a scientific level with partners in Medical Affairs (Global International Medical Directors or International Medical Directors or International Scientific Directors) with regard to study design and analysis to ensure that all studies are fit for purpose
-You will ensure that members of the project teams and management have a sufficient understanding of the methods applied and the results observed and/or inference drawn
-You will be responsible for the statistical components of publications and presentations
-You will manage consultants and outside collaborators that provide statistical and data management (Umbrella only) expertise for individual tasks or entire studies
-You will act as liaison between external contractor and team
-You will ensure that statistical activities performed within the study are executed in a timely manner and to the required high statistical and other reporting standards
-You will keep abreast of statistical methodological developments through literature and attendance at meetings
-You will keep abreast of regulatory authority guidelines relating to biostatistics and with medical issues in own project areas

IHRE QUALIFIKATIONEN:

-PhD or at least MSc (Diploma) in statistics or mathematics
-Good knowledge of the drug development process
-Good knowledge of GCP and regulatory guidelines
-Good knowledge of statistical methods for health outcome studies
-Good knowledge of the CRO business with a special focus on statistics and data management services provided
-Good knowledge of SAS and other statistical software packages
-Fluency in written and spoken English
-Experience working as a statistician in the pharmaceutical industry or CRO

WEITERE QUALIFIKATIONEN:

Biostatistician