Your responsibilities: 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 Biostatistical assurance of quality control for Fresenius Kabi company sponsored trials worldwide, including guidance and oversight of contract research organizations 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 Collaborate with internal and external functions (e.g. CROs) to ensure meeting project timelines and goals 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 clinical /non-clinical biostatistics in the pharmaceutical or biotechnology industry and/or CROs You are passionate about clinical development and analysis, comprehensive knowledge of statistical methodology in design and analysis needed for clinical research You bring knowledge of Real-World research methodology and innovative methodologies You have experience in adaptive study design You have experience with Bayesian methods Experience in PK/PD studies (BE studies) 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 the ability to work effectively in international teams and matrix organization with multi-disciplinary teams You enjoy working on challenging scientific projects in an international setting You have astrong communication skills to present and explain the methodology and consequences of decisions You are fluent in English (written & spoken)