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The successful candidate will join the Epidemiology and Biostatistics department and will be responsible for ensuring timeliness, quality and completeness of the statistical deliverables for their assigned Clinical Studies. He/she will be responsible for ensuring the results from Clinical Studies are reported accurately and ensuring the integrity of the statistical analysis.
Specifically, you will:
• Ensure that the statistical analysis and reporting processes are in accordance with Good Clinical Practices (GCP) and other guidance pertaining to statistical principles and apply these standards to the activities performed on the assigned clinical studies to ensure the quality and integrity of the results.
• Serve as study biostatistician and you will be accountable for the bio-statistical aspects of the assigned Clinical Studies. Bring bio-statistical input where needed in all study related documents (e.g., Study Protocols, Statistical Analysis Plans, Study Reports, publications, presentations).
• Manage the Clinical Research Organizations (CROs) executing statistical tasks. Develop project plans and timelines and track the study progress of statistical activities against these timelines to ensure that all appropriate activities have been performed and delivered on time with the expected quality.
• Apply bio-statistical principles, techniques and practices to develop the methodology to assess new alternative smoking product. Guide and monitor the selection of appropriate statistical methods for the design and data analysis of clinical studies.
• Interact with the study team and mentor them on statistical issues in order to best support the objectives of the Product Development Programs as a whole and individual clinical studies. Provide statistical expertise to the R&D program pre-clinical, pre- and post-marketing clinical studies and experiments to ensure consistency through the entire Product Development Program.
• MSc/PhD in bio-statistical, biometrics, or statistical field.
• Relevant experience in study design, conduct and analysis of clinical studies in pharmaceutical, consumer goods, or clinical research environment.
• Sound knowledge of the Statistical Principles for Clinical Trials
• Sound knowledge of CDISC ADaM Standards
• Good understanding of CDISC SDTM Standards
• Good knowledge of GCP
• Excellent knowledge of the SAS Product Suite
• Fluent English
if you are interested, please contact
Region: Neuchâtel
Vertragsart: Dauerhaft
Kategorie: Naturwissenschaft/Forschung
Veröffentlicht am: 02.10.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1410-16260
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
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