Sr. Lead Biostatistician - Oncology Evidence Generation
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What you'll do
- 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
What they're looking for
- 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 have
- 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)
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Labcorp is seeking a Senior Lead Biostatistician – Oncology Evidence Generation to join our team in Raleigh/Durham, NC.
Work Schedule: Monday - Friday, First Shift
Job Summary:
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.
Job 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
Minimum 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
Preferred Requirements:
- 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)
Additional Job Standards:
- Strong foundation in clinical study design and applied statistical leadership, including sample size estimation, power calculations, and endpoint evaluation
- Experience applying statistical methods to clinical, real-world, and/or assay validation datasets, including regression and survival/time-to-event analysis
- Strong written and verbal communication skills, with ability to clearly convey complex statistical concepts to diverse scientific and non-technical audiences
- Demonstrated ability to work effectively in cross-functional teams and collaborate with internal stakeholders and external partners
- Strong analytical, problem-solving, and organizational skills, with high attention to detail and commitment to data quality and scientific rigor
- Experience working in collaborative research environments involving academic or external investigator partnerships
- Occasional travel for internal meetings or external collaborator engagement, as needed (≤10–15%)
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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