Statistican

Rahmendaten

<p><strong>Start:</strong> August 2025<br> <strong>Duration:</strong> 12 months<br> <strong>Workload:</strong> ~2–3 days/week (0.5 FTE)<br> <strong>Language:</strong> Fluent German required<br> <strong>Location:</strong> Remote with occasional meetings (Germany-based client)</p> <h3><br> <strong>Project Context</strong></h3> <p>Our client – is preparing a <strong>G-BA (Gemeinsamer Bundesausschuss)</strong> submission following EMA approval. They are looking for an experienced <strong>freelance biostatistician</strong> who can take ownership of statistical analyses for the <strong>benefit assessment dossier (AMNOG process)</strong></p> <h3><strong>Key Responsibilities</strong></h3> <ul> <li> <p>Design and implement <strong>statistical analyses</strong> for clinical trial data to support the <strong>G-BA benefit dossier</strong></p> <li> <p>Collaborate in drafting the <strong>Statistical Analysis Plan (SAP)</strong> aligned with G-BA requirements</p> <li> <p>Independently run and validate analyses using <strong>SAS</strong> or comparable tools (e.g., R)</p> <li> <p>Ensure <strong>G-BA-compliant output formats</strong> (tables, figures, listings)</p> <li> <p>Coordinate with internal teams (regulatory, medical, market access) for submission timelines</p> <li> <p>Support data interpretation and input into <strong>value and evidence documents</strong></p> <li> <p>Deliver results ready for submission starting from <strong>October</strong>, once clinical data is available</p> </ul> <h3><br> <strong>Required Qualifications</strong></h3> <ul> <li> <p>Proven experience with <strong>G-BA / AMNOG dossiers</strong> in Germany</p> <li> <p>Solid background in <strong>biostatistics</strong> or <strong>clinical data science</strong></p> <li> <p>Hands-on skills in statistical programming (<strong>SAS</strong> essential, R/GBM optional)</p> <li> <p>Experience in designing and running <strong>clinical trial analyses</strong> (Phase I–III)</p> <li> <p>Familiarity with EMA submission processes is a plus</p> <li> <p>Fluent in <strong>German</strong> (spoken and written) – required for regulatory submissions</p> <li> <p>Ability to work independently and proactively in a cross-functional environment</p> </ul>