Senior Manager Biostatistics (m/f/d)

Job description

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 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 in...