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 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)