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, documenta...