Großraum Freiburg | Festanstellung durch unseren Kunden | hays-searchresults-startdate | 413035/1
Koordination und Vorantreiben des Fortschritts der CRO-Zusammenarbeit Beratung des Teams bei Planung, Konzeption und Interpretation von Studienergebnissen (klinische Entwicklung/v.a. späte Studienphasen) Überprüfung der Studiendokumente und Gewährleistung der Validierung und Qualitätskontrolle von statistischen Auswertungen Mitarbeit bei der Erstellung von Nutzendossiers (G-BA-Beratung, Erstellung relevanter Teile, Vorbereitung Anhörung)
Frankfurt on the Main | Permanent employment with our customer | hays-searchresults-startdate | 393680/3
Provide statistical input for Clinical Study Protocols, Clinical Study Reports, Clinical Development Plans, regulatory documents as well as publications for peer-reviewed journals Take part in cross-functional projects and represent statistics Calculate statistical analyses Develop statistical analysis plans and perform sample size calculations Collaborate with CROs and oversee their statistical work Ensure that quality standards (SOPs) are met
Bavaria | Permanent employment with our customer | hays-searchresults-startdate | 402405/3
Planning, set-up, execution, SAP as well as analysis/reporting and publication CRO coordination and oversight in close collaboration with project team(s) and Steering Committees Ensuring timely and accurate completion of biostatistical deliverables (internal tasks or tasks of CROs) Support the development, execution and implementation of the European HEOR strategy Planning, set-up and execution (by job holder or CRO) of additional statistical analyses as needed and requested by HEOR colleagues for national value dossiers Review of value dossiers to ensure proper description of statistical components of the dossier Active participation in meetings with HEOR/HTA authorities Sharing his/her experience and methodological knowledge internally with biostatistic colleagues and other departments Support other departments (Medical Affairs, Marketing, RWE & Late Phase Clinical Operations) in maximizing the success for the DSE portfolio in terms of Market Access Representing biostatistics internally and externally to ensure adequate implementation of statistical methodology