Team Lead SDTM (m/f/d)

Discipline leadership of the SDTM team (in Germany and prospectively other international locations) as well as resource planning and assignment for international projects Interpretation of new CDISC guidelines, further development of internal SDTM standards and mapping guidelines as well as ensuring uniform standards (cross-project and branch) Superordinate monitoring of project progress, risks and resources Ensure consistently high quality of SDTM-Deliverables across all projects and access to quality or time risks Coordination and coordination with interfaces (e.g. statistics, CDM, Medical Writing etc.) for higher-level SDTM topics participation in audits and inspections; Metadata and SDTM SOPs care Expenditure estimate for offer and budget planning in the SDTM environment

Completed study in a scientific or mathematical field Multiannual professional experience in SDTM, ideally with knowledge in early stages of study (phase 1/2) and in the regulated environment (GCP, ICH etc.) Multiannual leadership responsibility in SDTM or a comparable field Detectable experience in the further development and SDTM-compliant standardization and digitization of processes, ideally also in the international environment Planning, delegation and decision-making competence with a focus on cross-project responsibility and on the timely and correct creation of the SDTM-Deliverables Experience in the overarching process and decision-making responsibility for ICG-GCP and CDISC-compliant data structures and standards as well as maintenance of sponsor standards and automation Enthusiasm for the introduction and application of new technologies and continuous development of these technologies, such as AI solutions Very good knowledge of German and English in word and writing and routine in the international working environment Teamability, enforcing and target orientation as well as flexibility in addressing new challenges

A responsible leadership role in an international, scientifically influenced and growing environment A permanent employment with a long-term perspective in a future-oriented environment Structured integration and space for ownership and innovation Flexible working conditions with short decision paths A corporate culture characterized by trust, transparency and openness Attractive remuneration with annual inflation compensation Bicycle leasing (also e-bikes) via BusinessBike incl. free charging Corporate Benefits: exclusive employee discounts at over 800 providers EAP staff support program for professional short-term advice on health, professional and personal issues as well as the placement of specialist appointments