- Lead statistical design and analytical planning for oncology clinical utility studies
- Provide technical expertise in complex study design methodologies and data analyses
- Propose and justify efficient study designs for complex oncology use cases
- Serve as study statistician for multiple studies
- Collaborate with clinical, medical, and translational partners on study planning, development, and execution
- Identify risks, communicate concerns, and champion solutions to interdisciplinary teams and executive leaders
- Author and review statistical analysis plans, statistical reports, TLFs, CSRs, and publications
- Recommend and apply novel statistical approaches
- Mentor early-career statisticians
- Support continuous improvement of departmental processes, tools, and templates
- Collaborate on publication manuscripts
Requirements
- Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred)
- 4+ years of experience in clinical trial biostatistics
- Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology
- Expertise with innovative study design, including adaptive and biomarker-informed designs, power calculations, and endpoint evaluation
- Working knowledge of ICH and GCP guidelines and CDISC standards, including SDTM and ADaM
- Proficient in R
- Expert-level ability to independently design clinical studies
- Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation
- Ability to work in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds
- Ability to communicate complex statistical concepts clearly to technical and non-technical audiences
- Working knowledge of NGS-based diagnostics and ctDNA/MRD preferred
- Experience with non-inferiority studies preferred
Core Competencies
Demonstrates advanced expertise in Biostatistics and clinical trial design, with a strong focus on oncology applications, including time-to-event analysis and innovative study methodologies. Proven ability to mentor junior statisticians and collaborate effectively with interdisciplinary teams to drive study success.
Highest-signal resume keywords
- Ph.D. In Biostatistics
- Clinical Trial Biostatistics Experience
- Time-To-Event Analysis Expertise
- Proficient In R
- Knowledge Of ICH And GCP Guidelines
Hard Skills
- Statistical Design
- Data Analysis
- Survival Modeling
- Adaptive Study Design
- Power Calculations
- Endpoint Evaluation
- Biomarker Enabled Study Design
- Sample Size Determination
- Statistical Analysis Plans
- Statistical Reports
Soft Skills
- Communication
- Mentoring
- Collaboration
- Problem-Solving
- Interdisciplinary Teamwork
Industry Keywords
- Oncology
- Clinical Utility Studies
- CDISC Standards
- SDTM
- ADaM
- Non-Inferiority Studies
Tools & Technologies
- R
- NGS-Based Diagnostics
- CtDNA/MRD
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Lead Biostatistician – Oncology Clinical Studies Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
