Contribute to the development of German AMNOG dossiers, with a focus on programming of statistical analyses for Module 4
Perform scientific assessment and analysis of clinical trial data, including analysis of efficacy, safety, patient-relevant endpoints, and subgroup analyses
Perform meta-analyses and indirect treatment comparisons and support interpretation of statistical outputs
Contribute to the automation and standardization of analysis workflows to ensure efficiency, consistency, and reproducibility
Collaborate closely with cross functional teams (Market Access, HEOR, Medical Affairs, EU-HTA Team)
Ensure scientific quality, clarity, and consistency of generated outcomes
Monitor and interpret methodological developments from IQWiG, G BA, and relevant HTA bodies
Requirements
Master’s degree or PhD in biostatistics, data science, or a related field
Initial experience in HTA, AMNOG, HEOR, or Market Access (industry, consultancy, or research institute preferred) and/or in clinical development
Solid understanding of clinical study designs, endpoints, and statistical principles
Familiarity with clinical study data and the corresponding industry standards (CDISC SDTM/ADaM)
Familiarity with the German AMNOG process, IQWiG methodology, or G‑BA procedures is an advantage
Strong analytical skills and attention to detail
Ability to translate complex data into clear and structured output
Affinity for data and excellent analytical and conceptual skills
Strong background in statistics/data sciences/programming with a focus on process automation
2 years experience in advanced SAS programming, R programming skills are an advantage
2 years hands-on clinical data analysis experience with CDISC SDTM/ADaM datasets
Solid understanding of core statistical methods used in clinical trials and HEOR
Fluent German and English, written and spoken (this is an absolute must)