Sr Biostatistician – Oncology
Company: Syneos Health
Location: Remote – North America (USA / Canada)
Job Type: Full-Time | Remote
Experience: Typically 6–10+ Years (Clinical Trials / Biostatistics / Oncology Research)
Qualification: MS in Biostatistics or related discipline (PhD preferred)
Salary Range: Not Specified
Job Overview
Syneos Health is seeking a Senior Biostatistician – Oncology to lead statistical strategy and analysis across oncology clinical trials.
The Senior Biostatistician will serve as the primary statistical contact for sponsors, supporting study design, statistical analysis planning, simulation studies, and interpretation of clinical trial data. The role involves working closely with clinical teams, statistical programmers, and regulatory stakeholders to ensure high-quality statistical deliverables throughout the clinical trial lifecycle.
This position plays a key role in supporting oncology drug development programs, including early phase clinical studies, while ensuring compliance with global regulatory standards and industry best practices.
Key Responsibilities
1. Clinical Trial Statistical Leadership
Lead statistical activities across multiple clinical trials or programs.
Act as the primary statistical contact for sponsors and project teams.
Provide statistical expertise throughout the clinical trial lifecycle from protocol development to Clinical Study Report (CSR).
Direct the work of statisticians and statistical programmers on assigned projects.
2. Study Design & Statistical Strategy
Contribute to protocol development and clinical study design.
Develop statistical methodologies for oncology trials including adaptive designs such as BOIN (Bayesian Optimal Interval Design).
Run simulations to evaluate design alternatives and optimize study outcomes.
Provide statistical guidance on endpoint selection and study methodology.
3. Statistical Analysis Planning
Develop Statistical Analysis Plans (SAPs) and define analysis strategies.
Create mock-up displays for tables, listings, and figures (TLFs).
Review and validate programming specifications for analysis datasets.
Ensure statistical analysis aligns with protocol objectives and regulatory expectations.
4. Data Review & Statistical Output Verification
Review statistical outputs and ensure accuracy and quality of analysis results.
Perform quality control and validation of statistical deliverables.
Review datasets including SDTM and ADaM to ensure appropriate use for statistical outputs.
Ensure outputs are consistent with SAP and regulatory reporting requirements.
5. Oncology Clinical Trial Expertise
Support oncology clinical trials including pre-clinical, Phase I, and Phase II studies.
Analyze oncology-specific endpoints such as:
Overall Response Rate (ORR)
Progression-Free Survival (PFS)
Biomarker endpoints
Provide statistical support for pharmacokinetic and pharmacodynamic (PK/PD) analyses when required.
6. Regulatory & Documentation Support
Contribute statistical input to Investigator Brochures (IB) and Development Safety Update Reports (DSUR).
Participate in regulatory interactions and respond to statistical queries when needed.
Support statistical components of regulatory submissions and clinical study reports.
Ensure compliance with global regulatory guidelines including ICH standards.
7. Cross-Functional Collaboration
Collaborate with clinical development teams, data management, regulatory affairs, and statistical programming groups.
Represent biostatistics in cross-functional project team meetings.
Provide statistical insights and guidance to support clinical decision-making.
8. Leadership, Mentorship & Business Development
Mentor and coach junior biostatistics staff.
Coordinate statistical activities across multiple projects and timelines.
Support business development activities including proposal preparation and sponsor bid defense meetings.
Contribute to integrated analyses and strategic statistical planning.
Required Skills
Biostatistics & Clinical Research Expertise
Strong experience in clinical trial statistical design and analysis.
Experience supporting oncology drug development programs.
Ability to run simulations and evaluate alternative study designs.
Programming & Data Knowledge
Proficiency in statistical programming and analysis tools.
Familiarity with clinical trial datasets including SDTM and ADaM.
Experience reviewing statistical outputs and ensuring data quality.
Regulatory & Compliance Knowledge
Understanding of global clinical trial regulations and statistical guidelines.
Knowledge of ICH Good Clinical Practice (GCP) standards.
Experience supporting regulatory documentation and clinical reports.
Communication & Leadership
Strong stakeholder communication and collaboration skills.
Ability to lead statistical teams and manage multiple projects.
Experience mentoring junior statisticians and supporting cross-functional teams.
Preferred Qualifications
PhD in Biostatistics or related discipline.
Experience in oncology clinical trials.
Knowledge of PK/PD modeling and analysis.
Experience working within CRO or pharmaceutical clinical development environments.
Key Competencies
Oncology clinical trial statistics and data analysis
Statistical study design and simulation modeling
Clinical data review and statistical output validation
Regulatory statistical documentation and reporting
Cross-functional collaboration in clinical development
Leadership and mentorship within biostatistics teams
About the Company
Syneos Health is a global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercial expertise to accelerate therapy development. The company operates in over 110 countries with more than 29,000 employees, supporting pharmaceutical and biotechnology companies worldwide in delivering innovative therapies to patients.
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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