Sr. Lead Biostatistician - Oncology Evidence Generation

Labcorp•Durham, NC

4d•Onsite

About The Position

Labcorp is seeking a Senior Lead Biostatistician to join our cross-functional Evidence Generation team, supporting a growing portfolio of oncology research initiatives, with a focus on observational clinical validity studies in minimal residual disease (MRD), alongside investigator-initiated studies, registries, and real-world evidence programs. This role will serve as the statistical lead across multiple studies, driving study design, analytical strategy, and execution to ensure high-quality, scientifically rigorous outputs. The Senior Lead Biostatistician will act as a central statistical leader, partnering closely with clinical development, scientific, data, and operational teams, as well as external investigators and collaborators. This individual will ensure studies are appropriately designed, powered, and analyzed while delivering high-quality statistical outputs that support evidence generation, publication, and clinical adoption. The role plays a critical part in translating complex data into meaningful insights and advancing Labcorp’s precision oncology evidence strategy.

Requirements

MS in Biostatistics, Statistics, or a related quantitative field
6 or more years of experience in clinical biostatistics within biotechnology, diagnostics, CRO, or related healthcare environments
5 or more years of experience in statistical programming (R, SAS or equivalent acceptable)
3 or more years of experience supporting clinical research studies, including observational studies, registries, and/or assay validation efforts
3 or more years of experience independently managing statistical analyses and deliverables across multiple concurrent studies

Nice To Haves

PhD in Biostatistics, Statistics, or a related quantitative field
3 or more years of experience in oncology research, biomarker-driven studies, or precision oncology
3 or more years of experience with real-world data, registry-based research, or observational study designs
3 or more years of experience contributing to scientific publications, including abstracts, manuscripts, or conference presentations
1 or more years of experience with MRD, ctDNA, genomics/NGS-based assays, or molecular diagnostics
1 or more years of experience with clinical study documentation and regulatory standards (e.g., protocols, SAPs, GCP principles)

Responsibilities

Contribute to and shape the design of MRD-focused studies, including clinical validity studies, registries, and real-world evidence programs, defining endpoints, analysis strategies, and overall statistical approach across multiple concurrent programs
Perform sample size and power calculations, support endpoint justification, and draft statistical sections of study protocols
Independently perform statistical analyses across diverse datasets (clinical, assay/validation, and real-world/registry data) using appropriate methods (e.g., regression, survival analysis, validation approaches), ensuring accuracy, reproducibility, and appropriate documentation
Serve as the statistical point of contact for assigned studies; partner with clinical, translational, and data teams, as well as external collaborators, to support study execution and communicate statistical concepts, methods, and results clearly to non-statistical stakeholders
Identify study risks and provide data-driven recommendations to support study integrity and decision-making
Develop, manage, and maintain statistical deliverables (analysis summaries, tables/listings/figures, study reports) and lead or contribute to the development of Statistical Analysis Plans (SAPs)
Contribute to abstracts, manuscripts, and scientific presentations supporting evidence generation and publication strategy
Manage statistical deliverables across multiple concurrent studies, ensuring timelines, quality, and consistency of outputs
Lead or contribute to development of statistical templates, tools, and workflows, while building subject matter expertise in MRD and oncology study methodologies