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Management, review and evaluation of biostatistical solutions and strategies for pre-clinical and clinical studies (phase 1-4, non-interventional incl. RWE studies) conducted and supported by Fresenius Kabi
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Biostatistical assurance of quality control for Fresenius Kabi company sponsored trials worldwide, including guidance and oversight of contract research organizations to ensure project timelines and goals
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Study planning, including study design discussions and sample size calculations
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Development of statistical analysis plans (SAPs)
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Conduct of statistical analyses and interpretation of statistical results
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Contribution to clinical study reports, including integrated summaries for submissions
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Participate in the development of CRFs, edit check specifications, and data validation plans
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Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
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Statistical programming for Quality Control of critical outputs
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You have a completed university degree in (Bio-) statistics or mathematics or equivalent
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You have at least 5 years experience in CROs and / or the pharmaceutical/biotechnology industry
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You enjoy working on challenging scientific projects in an international setting and in multidisciplinary teams
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You are passionate about clinical development and analysis, comprehensive knowledge of statistical methodology in design and analysis needed for clinical research
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You are highly motivated to explore and implement AI‑supported methods for practical biostatistical applications and efficiency gains in clinical studies
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You bring knowledge of Real-World research methodology
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Experience in PK/PD studies (BE studies) / adaptive designs is a plus
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Excellent knowledge of SAS is mandatory, knowledge of R programming is a plus
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You have a solid understanding & implementation of CDISC requirements for regulatory submissions (in particular ADaM)
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You have strong communication skills to present and explain the methodology and consequences of decisions
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You are fluent in English (written & spoken)