12.03.2026 aktualisiert
100 % verfügbar
Senior Biostatistician
Hamburg, Deutschland
Nur Remote
MSc BiostatisticsÜber mich
Biostatistician with 15+ years of experience in Phase I–IV clinical studies (CRO and pharmaceutical settings). Expertise in study design, estimands, SAP/CTR authoring, sample size calculation, randomization and unblinding procedures, SAS programming, CDISC implementation, and regulatory submissions.
Skills
Data AnalysisKünstliche Neurale NetzwerkePartnerschaftenVerwaltung Klinischer DatenRepository für Klinische DatenKlinische ForschungGeneralisierte Lineare ModelleLatexLineare RegressionLineares ModellMachine LearningProjektmanagementSasStatistikenBestimmung des Stichprobenumfangs
Statistical Programming and Analysis
Advanced expertise in SAS programming, statistical modeling, and clinical trial data analysis with 15+ years of experience across Phase I-IV clinical development
Clinical Trial Design and Management
Comprehensive knowledge in study design, estimand definition, sample size determination, randomization procedures, and regulatory submissions for clinical trials
Regulatory and Documentation Excellence
Proficient in authoring and reviewing essential clinical trial documents including CTPs, SAPs, CTRs, and managing regulatory submissions for pharmaceutical studies
Programming Languages and Tools
Expert proficiency in R, VBA, nQuery, LaTeX, Git, and various statistical software packages for data analysis and reporting
Database Management and CDISC Standards
Extensive experience with SDTM, AdaM datasets, TLFs implementation, and CDISC standards compliance for clinical data management
Advanced Statistical Methods
Deep knowledge in linear regression, generalized linear models, mixed linear models, multiple imputations, and various statistical testing methods
Data Science and Machine Learning
Skills in KNN, SVM, neural networks, and modern data science techniques for complex clinical data analysis
Project Management and Leadership
Proven track record in leading cross-functional teams, managing departmental budgets, and scaling biostatistics operations across CRO partnerships
Advanced expertise in SAS programming, statistical modeling, and clinical trial data analysis with 15+ years of experience across Phase I-IV clinical development
Clinical Trial Design and Management
Comprehensive knowledge in study design, estimand definition, sample size determination, randomization procedures, and regulatory submissions for clinical trials
Regulatory and Documentation Excellence
Proficient in authoring and reviewing essential clinical trial documents including CTPs, SAPs, CTRs, and managing regulatory submissions for pharmaceutical studies
Programming Languages and Tools
Expert proficiency in R, VBA, nQuery, LaTeX, Git, and various statistical software packages for data analysis and reporting
Database Management and CDISC Standards
Extensive experience with SDTM, AdaM datasets, TLFs implementation, and CDISC standards compliance for clinical data management
Advanced Statistical Methods
Deep knowledge in linear regression, generalized linear models, mixed linear models, multiple imputations, and various statistical testing methods
Data Science and Machine Learning
Skills in KNN, SVM, neural networks, and modern data science techniques for complex clinical data analysis
Project Management and Leadership
Proven track record in leading cross-functional teams, managing departmental budgets, and scaling biostatistics operations across CRO partnerships
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Plan and allocate resources, estimate and manage project budgets, serve as primary point of contact for clients, support bid defense meetings, serve as statistical lead for Phase I-III clinical trials including study design and analysis planning
Served as statistical lead for Phase I-III clinical trials, designed and conducted analyses in gastroenterology and medical devices, authored and reviewed essential clinical trial documents, performed sample size and power calculations
Planned departmental budgets, authored and maintained SOPs/WIs, developed statistical models in R, generated business insights and identified business opportunities, estimated biological age from epigenetic data