Associate Director Lead Statistician- Oncology
Employment Type: Full-Time
The Associate Director Lead Statistician- Oncology Plays a key role in the design, analysis, and reporting of medical affairs activities (for example post-marketing clinical and observational studies, publications, reimbursement dossiers) that are performed by or under the responsibility of Bayer Medical Affairs Oncology. The incumbent coordinates statistical work and leads all statistical functions and staff for one or more drug projects for Bayer Medical Affairs Oncology and also serves as an in-house consultant on methodological issues. YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Associate Director Lead Statistician - Oncology, are to: Takes the statistical lead for Oncology Medical Affairs activities for one or more projects, thus facilitating the overall organization and coordination of all statistical activities associated with Oncology Medical Affairs activities for these projects; Provides statistical and methodological consultation and contributes to multi-disciplinary and multi-company teams. Plans and performs exploratory analyses on internal and external databases; Facilitates the overall organization and coordination of statistical aspects for Oncology Medical Affairs for important studies and projects Leads virtual teams of statisticians and representatives of other functions; Influences decision making processes during oncology drug development and life-cycle management by use of appropriate statistical methodology (e.g. simulations, meta-analyses or modeling approaches); Keeps abreast of regulatory and methodological issues and ensures communication of these in the respective teams. Develops and implements innovative statistical methodology for the respective field of responsibility, if appropriate in cooperation with academic experts; Leads the development and evolution of standard processes for routine assessments associated with Oncology Medical Affair requests as well as project specific standards; Responds to inquiries from health authorities and other internal or external partners the results of clinical trials provide the basis of government approval of each drug and must be presented so as to conform to strict regulatory (e.g. FDA, EMA) standards. This entails the design and analysis of clinical trials and the writing of statistical reports to be submitted to authorities as a crucial part of our New Drug Application (NDA) for each product Statistics and statistical methodology are thus integral parts of drug development and life-cycle management in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance; The lead medical affairs statistician contributes to drug research, the development of new drugs, the approval of new drugs by health and reimbursement authorities, and the life-cycle management of marketed drugs according to the major tasks and responsibilities of the position.Also, the lead medical affairs statistician facilitates risk management decisions within our company through the development and implementation. WHO YOU ARE Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications: • PhD or MSc in Biostatistics, Statistics or Mathematics, or related field; • Excellent interpersonal, leadership and communication skills; • Ability to work independently as well as collaboratively, as required; • Excellent knowledge of statistical programming languages (including SAS and R); • Fluent English skills; • At least four years as a statistician with significant time spend in pharma, biotech or similar sector; • Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations; • Experience in leading teams of statisticians and/or representatives from other functions; • High level of expertise in multiple fields relevant for medical affairs within Oncology Development
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