1 job found in Genève

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    • genève, genève
    • contract
    Do you have a significant experience in biostatistics?Are you knowledgeable in clinical trials and regulatory requirements? Are you recognized for your organizational skills? Are you available immediately or soon and looking for your next challenge?In this case, you should have a look at this opportunity! Our client, an international biotechnology industry based in the Geneva area, is looking for a: Senior Manager Biostatistics (temporary contract - 5 months with possible extension) Main Tasks:Contribute to the development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission package, interactions with Health AuthoritiesLead or responsible for the oversight of Statistical Analyses Plans and other statistical deliverables.For projects under direct responsibility:o provide input for detailed timelines forecasting for biostatistics related deliverables.o Actively contribute to cost tracking related to the functional deliverableso biostatistics representative for audits and inspectionsManage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues according to the level of expertise.Effectively collaborate with Biostatistics, Programming and Data Management colleagues as well as with Pharmacometrician for input and information exchange to facilitate best practices across all studies/programs.Participate in CRO selection process and provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.Provide input to process improvement: assess new methodologies or technologies when applicable; contribute to the development, review and update of BDM SOPs as company/situations evolve.Collaborate effectively with cross-functional teams and external partners.Maintain strong and broad based statistical expertise. Required Profile: Education: Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related Discipline Work experience:10+ years of related industry experience within the functional area.Strong SAS expertise Job Specific Competencies & Skills: Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective.Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)Strong communication skills; verbal, written, and presentation.Highly motivated and enjoys working in a fast-paced environment.Strong organizational skills and the ability to prioritize and multi-task.Positive, flexible self-starter who thrives under pressure. Languages:English fluent If you recognize yourself in this ad, don't wait any longer and apply now!  
    Do you have a significant experience in biostatistics?Are you knowledgeable in clinical trials and regulatory requirements? Are you recognized for your organizational skills? Are you available immediately or soon and looking for your next challenge?In this case, you should have a look at this opportunity! Our client, an international biotechnology industry based in the Geneva area, is looking for a: Senior Manager Biostatistics (temporary contract - 5 months with possible extension) Main Tasks:Contribute to the development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission package, interactions with Health AuthoritiesLead or responsible for the oversight of Statistical Analyses Plans and other statistical deliverables.For projects under direct responsibility:o provide input for detailed timelines forecasting for biostatistics related deliverables.o Actively contribute to cost tracking related to the functional deliverableso biostatistics representative for audits and inspectionsManage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues according to the level of expertise.Effectively collaborate with Biostatistics, Programming and Data Management colleagues as well as with Pharmacometrician for input and information exchange to facilitate best practices across all studies/programs.Participate in CRO selection process and provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.Provide input to process improvement: assess new methodologies or technologies when applicable; contribute to the development, review and update of BDM SOPs as company/situations evolve.Collaborate effectively with cross-functional teams and external partners.Maintain strong and broad based statistical expertise. Required Profile: Education: Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related Discipline Work experience:10+ years of related industry experience within the functional area.Strong SAS expertise Job Specific Competencies & Skills: Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective.Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)Strong communication skills; verbal, written, and presentation.Highly motivated and enjoys working in a fast-paced environment.Strong organizational skills and the ability to prioritize and multi-task.Positive, flexible self-starter who thrives under pressure. Languages:English fluent If you recognize yourself in this ad, don't wait any longer and apply now!  

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