Research Associate / Research Associate Pharmacometrics (m/f/d)

We are looking for our SBD5 Data Science and Methods department at the next possible time Research assistant / Senior Consultant (m/w/d) We, the Paul-Ehrlich-Institut, are a scientific institution of the Federal Institute responsible for the testing and approval of vaccines and biomedical medicinal products and for research in the field of life sciences. Networking with national and international actors makes us a competent partner for the public, science, medicine, politics and business. The SBD5 area ... supports the Institute's departments by providing mathematical and statistical expertise in the fields of activity regulation and research. A motivated team will support you in the process and look forward to working with you. A varied and responsible activity awaits you in interdisciplinary project teams.

Assessment of pharmacometric aspects and methods and, where appropriate, evaluation of submitted data with regard to MIDD (Model-informed drug development) by means of PopPKPD (Population-Pharmacokinetic-Pharmacodynamic), QSP (Quantitative Systems Pharmacology) and related approaches as part of applications for authorisation, in the scientific advice of drug developers (national and European) and approval of clinical trials

Support for mathematical modelling research Representation of the Institute and participation in national/international bodies in the medium term Cooperation in the development of regulatory guidelines for biomedical medicinal products and the establishment of guidelines

Completed university studies (master or comparable) of pharmacy, human medicine, natural science, mathematics or a related study programme Promotion desirable Comprehensive knowledge and experience in pharmacometry Expertise in the application of software for data analysis and mathematical modeling desired (e.g. NONMEM, Monolix, R, Simcyp) Interest in clinical and pharmacological issues Regulatory experience is advantageous Very good German and English language skills in word and writing Impressed analytical thinking, rapid understanding and structured, independent working methods Teamability, communication strength and the ability and willingness to work together in an interdisciplinary manner

Please note that a Declaration of Interests vis-à-vis the EMA as well as a statement in accordance with § 77a AMG must be submitted in the event of the conclusion of the contract.

is a versatile and demanding workstation centrally located in the Rhine-Main area with good connections to the public transport network (car, airport, S-Bahn). As an employer of the public service, we offer the usual social benefits, such as special payments for the year, pensions and benefits. The employment ratio is limited to 3 years. Parttime employment is generally possible. The post is rated according to E 14 TVöD, part I of Appendix 1 of the TVEntgO Bund. The assignment to the stages takes place taking into account the personal relevant experience. Disabled applicants (m/w/d) are preferably taken into account with the same suitability. The Paul-Ehrlich-Institut promotes the equality of people and the reconciliation of family and work. For this purpose, we offer, inter alia, very flexible working times (part-time models, no core working times), hybrid work (max. 60% remote), kindergartens and numerous training opportunities. Our occupational health management and the promotion of the job ticket complete the offer. .