Medical Statistician (m/f/d)
SmartStep Consulting - Hamburg
Full-time
Permanent employee
Our vision
The medical statistician works in interdisciplinary project teams to develop and implement evidence-based strategies for assessing the benefits of innovative therapies. Some projects focus specifically on the German AMNOG process, while others are guided by European standards such as the EU HTA. The projects and programs span various areas, including epidemiological analyses, statistical modeling, scientific communication, regulatory hearings, and strategic data interpretation. The medical statistician plays a key role in strengthening evidence-based decision-making in healthcare and enabling patients to gain faster access to innovative therapies.
Your mission
- Assisting with the evaluation and assessment of medical statistical issues in connection with benefit assessments pursuant to Section 35a of the German Social Code, Book V (SGB V) (AMNOG / EU-HTA).
- Conducting epidemiological analyses and evaluating their results, including the preparation of scientific publications; the statistical analysis of clinical trials and providing consulting support to pharmaceutical and medical device companies are key focuses of this role.
- Researching and implementing appropriate statistical methods for the analysis of secondary data-based and clinical studies.
- Contribute to the development and quality assurance of method descriptions during various phases of the AMNOG process (e.g., as part of Module 4 of the benefit assessment dossier), as well as provide support in preparing for oral hearings.
Your profile
- A degree in mathematics, statistics, bioinformatics, biomathematics, or a comparable field of study
- Skills in developing, testing, and integrating analytical statistical models and methods
- Very good knowledge of the R programming language; knowledge of SAS is desirable
- Experience with Git and applied statistics
- Skills in scientific writing and communication (drafting scientific manuscripts, reviewing benefit assessment dossiers, providing scientific descriptions of statistical methodologies, preparing expert opinions, and preparing for and participating in hearings)
- Experience in analyzing health-related secondary data
- Openness to the use of new technologies, particularly AI-supported applications
- A high degree of initiative, analytical thinking, and problem-solving skills, combined with a meticulous and reliable work ethic
- Strong communication skills, including the ability to discuss methods, procedures, and the interpretation of results with non-specialists
- Fluency in spoken and written German and English
About us
SmartStep Consulting offers customized, highly specialized services for the pharmaceutical and medical technology industries to enable patients quick access to new and better treatment options. As part of the G&L Group, SmartStep aims to expand its services and leverage international opportunities arising from the new EU-HTA procedures.