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)
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With over 41,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
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