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(Senior) Biostatistician (m/f/d)
Frankfurt am Main
Aktualität: 27.09.2021

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27.09.2021, Merz Aesthetics
Frankfurt am Main
(Senior) Biostatistician (m/f/d)
You provide statistical input to clinical development programs and clinical trials / investigations, including Clinical Development Plans, CTDs, etc. You define statistical aspects of a clinical trial in the Clinical Trial Protocol including writing the Statistical Analysis Section You review and provide input to Clinical Trial Protocols, Clinical Study Reports, etc. You deliver input to data collection instruments (e.g. CRF, diary), data management and data validation processes (e.g. data validation checks), definiton of risk-based monitoring procedures (e.g. signal detection process) and other aspects of data collection and validation You specify, coordinate or conduct and quality control the statistical analysis activities for individual studies and integrated analyses (e.g. ISE, ISS). You define randomization process details; initiate, coordinate and conduct unblinding process You oversee statistical activities outsourced to CRO You coordinate and discuss all statistical aspects in interaction with regulatory bodies such as Scientific Advice Meetings You review and provide input to scientific publications and present study results You interact with other R&D functions and Medical Affairs including consultation on statistical topics (e.g. in preclinical projects, publications, etc.) You optimize and update biostatistics processes to reflect possible changes in regulatory and organizational requirements
Graduate studies in Statistics, Mathematics, Natural Sciences or similar At least 3 years experience in Biostatistics Business fluent in English (written and spoken) Familiarity with ICH, GCP, FDA guidelines Experience with EDC systems and SAS, ideally experience with CDISC data standards Strategic and analytical thinking Excellent communicating and team player skills High sense of responsibility and quality awarenessess Analytical and highly structured way of working

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(Senior) Biostatistician (m­­/­­f­­/­­d)

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Frankfurt am Main