Debiopharm International SA·Pharmaceuticals·Lausanne, Waadt
Head of Biostatistics & Data Management 100 %
PositionVollzeit · Festanstellung · Director · Wissenschaft & Forschung
Konditionen100%
Anforderungen12+ J. Erfahrung · Doktortitel · EU/EFTA-Bewilligung
Deine Übereinstimmung
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Skills
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GCPCommunicationStatistical programmingICH guidelinesAIInnovationData ManagementProject management softwareData AnalysisPharmaceutical developmentDigitalisierungRegulatory Compliance in Medicine
Sprachen
Englisch
Die Stelle
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01Strategic Leadership and Team Development: Lead, align, and motivate the Biostatistics and Data Management organization to ensure unwavering commitment and engagement.
02Statistical and Methodological Oversight: Supervise and provide guidance on statistical design methodology across programs.
03Regulatory and Compliance Command: Take responsibility for the statistical components of Clinical Trial Reports for all regulatory submissions.
04Cross-Functional Collaboration and Communication: Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Translational Medicine.
Anforderungen
↳A Ph.D. in Statistics, Biostatistics, Mathematics, or a related field
↳A minimum of 12 years of experience in the biotech or pharmaceutical industry, with at least 8 years leading Biostatistics, Statistical Programming, and Clinical Data Management functions
↳Proven expertise in clinical and pharmaceutical industry experience in planning and conducting clinical trials
↳Demonstrated expertise in statistical design and planning, data analysis, and reporting of clinical trial data