CSL Behring is one of the world's leading manufacturers and providers of innovative, life-saving pharmaceuticals made from human plasma as well as related treatments. The company has approximately 12,000 employees globally, of which there are about 2,300 in Germany at the largest production and research location of CSL Behring in Marburg.
People who work for CSL Behring are committed to saving the lives of patients throughout the world. This involves top performance, as we strive to be the best. Join our team in the Pharmacology & Toxicology department as a
Biostatistics, Pharmacokinetics Expert (f/m)
Provide statistical expertise across preclinical research and development projects.
Responsible for design, evaluation and reporting of pharmacokinetic studies.
Liaises with other biostatistics experts across CSL sites.
Project lead for selected research or development projects in local or global project teams.
Plan, monitor, analyze and report preclinical pharmacology and toxicology studies.
Qualifications, Experience and Competencies
Master’s degree or preferably PhD in Statistics, Biostatistics, Pharmacokinetics, or related field with relevant experience in clinical or preclinical research. Alternatively, relevant Life Science Degree with in depth experience in pharmacokinetic and/or biostatistical methods.
Demonstrated knowledge of the current regulatory requirements relating to statistical analysis, study reports, and data management standards of new drug applications.
Relevant experience in statistical and/or pharmacokinetic evaluation of preclinical or clinical data ideally within the CRO/pharmaceutical industry environment including writing and reviewing statistical and/or pharmacokinetic data reports as well as standard operating procedures.
Participate in development of preclinical study protocols including sample size calculations, randomization, dose and exposure modelling. Perform, present and review statistical analyses of preclinical pharmacokinetic, pharmacodynamic (efficacy) and safety studies or method validations.
Oversee preclinical database design and testing of data management system and thereby ensure quality and consistency of preclinical data.
Preferably experience in preclinical development of pharmaceuticals and / or analytical methods.
Advanced knowledge of at least one widely used software package for statistical evaluation of preclinical or clinical data.
Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.
Excellent communication, planning, organizational and analytical skills.
Ability to work successfully in a matrix organizational structure.
Fluent in English, oral and written. Basic German or willingness to learn German.
What you need to know CSL Behring offers an adequate, performance-oriented salary with an attractive bonus system as well as an excellent company retirement plan consisting of early pension schemes and a top-notch supplementary retirement provision. Our employees also have the benefit of flexible working hours. In order to optimally coordinate career and family, we offer an option at our day-care centre for small children, as well as school vacation care for school-aged children and an option for caregiver leave.
Interested? Then we are looking forward to receiving your comprehensive Online-Application.