Lead Biostatistician – Oncology Clinical Studies

Jobtailor; Deutschland; Remote; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks a seasoned biostatistician to lead statistical design and analysis for oncology clinical utility studies. You will provide expert input on complex study designs and collaborate with cross-functional teams to drive study planning, execution, and reporting.

The role requires a Ph.D. (preferred) with 4+ years in clinical trial biostatistics, strong R skills, and experience with CDISC SDTM/ADaM. You will mentor junior statisticians and contribute to methodological advances.

Qualifikationen

• Ph.D. in Biostatistics or related quantitative field is preferred.
• 4+ years of experience in clinical trial biostatistics.
• Strong expertise in time-to-event analysis and survival modeling.
• Experience with adaptive/biomarker-informed designs and power calculations.
• Familiarity with ICH/GCP and CDISC standards including SDTM and ADaM.
• Proficient in R and independent study design capability.

Aufgaben

• Lead statistical design and analytical planning for oncology clinical utility studies.
• Provide technical expertise in complex study design methodologies and data analyses.
• Propose 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 and execution.
• Identify risks and champion solutions to interdisciplinary teams and leadership.
• Author and review SAPs, statistical reports, TLFs, CSRs, and publications.
• Mentor early-career statisticians.
• Support continuous improvement of departmental processes, tools, and templates.

Kenntnisse

Time-to-event analysis

Clinical trial design

R programming

ICH/GCP knowledge

Data interpretation

Cross-functional collaboration

Ausbildung

Ph.D. in Biostatistics

Tools

R

CDISC SDTM/ADaM

Jobbeschreibung

• 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