Sr Biostatistician

Timeline: 12 months

Location: Remote, Pacific working hours overlap

Position Summary:

Our client is seeking an experienced Biostatistician to support late-phase oncology clinical development programs within a growing Clinical Development team. This is a hands-on, individual contributor role requiring both strong statistical expertise and the ability to independently execute statistical programming activities.

The ideal candidate will have direct oncology clinical trial experience, a strong understanding of study design and statistical methodologies, and the technical ability to develop and QC key statistical deliverables. This individual will work closely with Clinical Operations, Data Management, Statistical Programming, Medical Writing, and Regulatory teams in a lean team environment, requiring a high degree of independence and the ability to manage competing priorities.

• Provide statistical support for late-phase oncology clinical trials, from protocol development through Clinical Study Report (CSR) delivery.
• Contribute to study design, protocol development, and Statistical Analysis Plan (SAP) development and review.
• Independently perform statistical programming activities, including Tables, Listings, and Figures (TLFs) development.
• Develop and QC statistical programming shells, specifications, and associated study deliverables.
• Review statistical analyses and outputs to ensure accuracy, quality, and regulatory compliance.
• Collaborate with statistical programming teams and cross-functional stakeholders to support study execution and delivery.
• Interpret clinical study results and contribute to the preparation and review of CSRs and regulatory submissions.
• Manage assigned responsibilities independently in a small, hands-on team environment.

• MS or PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline.
• Minimum of 5+ years of biopharmaceutical industry experience.
• Direct experience supporting oncology clinical trials (solid tumor), preferably in late-phase development.
• Strong understanding of clinical trial methodology, including study design, SAP development, and statistical analysis.
• Hands-on statistical programming experience, including TLF development and QC of shells and specifications.
• Experience supporting CSR delivery and reviewing statistical outputs.
• Ability to work independently, manage multiple priorities, and take ownership of deliverables within a small team environment.
• Strong communication and cross-functional collaboration skills.
• Experience supporting regulatory submissions and late-phase oncology programs.