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