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
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)