Statistican
Rahmendaten
Start: August 2025
Duration: 12 months
Workload: ~2–3 days/week (0.5 FTE)
Language: Fluent German required
Location: Remote with occasional meetings (Germany-based client)
Project Context
Our client – is preparing a G-BA (Gemeinsamer Bundesausschuss) submission following EMA approval. They are looking for an experienced freelance biostatistician who can take ownership of statistical analyses for the benefit assessment dossier (AMNOG process)
Key Responsibilities
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Design and implement statistical analyses for clinical trial data to support the G-BA benefit dossier
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Collaborate in drafting the Statistical Analysis Plan (SAP) aligned with G-BA requirements
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Independently run and validate analyses using SAS or comparable tools (e.g., R)
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Ensure G-BA-compliant output formats (tables, figures, listings)
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Coordinate with internal teams (regulatory, medical, market access) for submission timelines
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Support data interpretation and input into value and evidence documents
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Deliver results ready for submission starting from October, once clinical data is available
Required Qualifications
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Proven experience with G-BA / AMNOG dossiers in Germany
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Solid background in biostatistics or clinical data science
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Hands-on skills in statistical programming (SAS essential, R/GBM optional)
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Experience in designing and running clinical trial analyses (Phase I–III)
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Familiarity with EMA submission processes is a plus
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Fluent in German (spoken and written) – required for regulatory submissions
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Ability to work independently and proactively in a cross-functional environment
