Principal Biostatistician

Jobtailor; Deutschland; Remote; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks a lead biostatistician to design and oversee oncology clinical studies. You will guide advanced time-to-event analyses, biomarker-informed designs, and adaptive methods, while mentoring junior statisticians and collaborating with cross-functional teams.

The role requires a PhD and 15+ years in biostatistics with strong CDISC/SDTM/ADaM expertise, and a track record of study design leadership in fast-paced environments.

Qualifikationen

• Advanced degree in Biostatistics, Statistics, or related quantitative field (Ph.D. preferred).
• 15+ years of experience in clinical trial biostatistics.

Aufgaben

• 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 tailored to complex oncology use cases.
• Serve as study statistician for Natera-sponsored studies and consultations for external collaborations.
• Partner with clinical, medical, and translational scientists 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, reports, tables, listings, figures, clinical study reports, 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.

Kenntnisse

Time-to-event analysis

Survival modeling

Complex study design

Communication of statistics

Mentoring

Ausbildung

Ph.D. in Biostatistics/Statistics

Tools

R

CDISC Standards

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 tailored to complex oncology use cases
• Serve as study statistician for Natera-sponsored studies and provide consultations for external collaborations
• Partner with clinical, medical, and translational scientists 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, tables, listings, figures, clinical study reports, 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)
• 15+ 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
• Preferred: Working knowledge of NGS-based diagnostics and ctDNA/MRD
• Preferred: Experience with non-inferiority studies

Core Competencies

Demonstrates advanced expertise in biostatistics and clinical trial design, particularly in oncology, with a strong focus on time-to-event analysis and innovative study methodologies. Proven ability to mentor junior statisticians and collaborate effectively with cross-functional teams to drive study execution and publication.

Highest-signal resume keywords

• Ph.D. In Biostatistics
• 15+ Years Clinical Trial Biostatistics Experience
• Time-To-Event Analysis Expertise
• Proficient In R
• Working Knowledge Of ICH And GCP Guidelines

Hard Skills

• Statistical Design
• Data Analysis
• Survival Modeling
• Adaptive Study Design
• Biomarker-Informed Designs
• Sample Size Determination
• Endpoint Evaluation
• Statistical Analysis Plans
• Statistical Reports
• Clinical Study Reports

Soft Skills

• Communication
• Mentoring
• Collaboration
• Problem-Solving
• Interdisciplinary Teamwork

Industry Keywords

• Oncology
• Clinical Trials
• NGS-Based Diagnostics
• CtDNA
• MRD
• Non-Inferiority Studies

Tools & Technologies

• R
• CDISC Standards
• SDTM
• ADaM