Proven expertise in Real-World Data/Evidence (EMR, Claims, Registry data) with more than 20 years of experience designing and executing RWE/HTA/HEOR studies for top pharma clients
Hands-on programming excellence in both SAS and R (including R Shiny, R Studio, and visualization tools) with extensive experience in developing automated analytics pipelines, interactive dashboards and regulatory-ready deliverables
Strong regulatory and submission background, having led the preparation of Statistical Analysis Plans, TFLs and CDISC-compliant submission packages supporting FDA/EMA and HTA/pricing dossiers across multiple therapeutic areas
Senior leadership and communication skills, consistently acting as Lead Statistician or SME, managing international project teams, engaging directly with clients and ensuring timely, high-quality statistical analyses for decisionmaking and regulatory use
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- University, Applied Statistics, Ph.D.; Statistics, Master of Science
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- RWE & RWD (EMR, Claims, Registry), SAS & R Programming (incl. R Shiny, R Studio, Visualization Tools), Development of SAPs, TFLs, HTA submission packages, Interactive Dashboards & Visual Analytics, Advanced statistical methodologies, Leadership
Key-Facts
Extract from previous activities
Clinical Research & Pharmaceuticals Company
Lead Statistician (RWE, HTA & Oncology)
Supported oncology-focused RWD/HTA submissions using survival and time-to-event methodologies
Conducted network meta-analyses for pooled survival outcomes across multiple studies
Developed and deployed R Shiny applications to visualize treatment effect heterogeneity
Authored statistical contributions to HTA submission dossiers for oncology indications
Global Pharmaceutical & Biopharmaceutical Company
Project Lead Statistician (Observational Studies)
Designed observational and late-phase safety studies in CVRM and Respiratory areas
Supported medical affairs, HTA dossiers, and peerreviewed publications with robust RWE analyses
Created R code and interactive dashboards (R Shiny) for internal evidence review
Acted as statistical QC lead, ensuring validity of methodologies used across ongoing RWE studies
Multinational Pharmaceutical & Biotechnology Company
Package Developer
Built metadata-driven automated reporting tools in R & R Shiny for efficacy/safety datasets
Developed custom R packages enabling reproducible analytics and interactive visualization of patient outcomes
Reviewed R code and ensured compliance with ICH E9, CDISC, and regulatory guidance
Applied Agile and DevOps practices on Azure (Databricks, DataLake) for scalable delivery
Pharmaceutical & Biopharmaceutical Company
Project Statistician (Early Phase I/II)
Provided statistical support for PK/PD and ECG modeling in early clinical studies
Authored and reviewed SAPs, study synopses, and protocols
Developed R Shiny applications for trial oversight, risk modeling, and audit readiness
Coordinated with health authorities on statistical methodologies prior to submission