Study-Level Biostatistician / Senior Biostatistician

We are looking for a full-time Study-Level Biostatistician to support clinical trial projects in a CRO/FSP environment. The role is hands-on and focused on the development and review of study-level statistical documents, including Statistical Analysis Plans, statistical input to study documents, review of mock shells, and QC/review of Tables, Listings, and Figures.

The ideal candidate should have strong clinical trials biostatistics experience, excellent written and spoken English, and the ability to work independently with project teams, statistical programmers, and client stakeholders. Experience in ophthalmology and/or oncology therapeutic areas is strongly preferred.

Key Responsibilities

• Develop, review, and provide input into Statistical Analysis Plans.
• Provide statistical input into protocols, study-level documents, mock shells, and analysis specifications.
• Review Tables, Listings, and Figures for consistency with the protocol, SAP, mock shells, and statistical methodology.
• Perform statistical QC/review of outputs and provide clear comments to statistical programmers.
• Support definition of endpoints, analysis populations, visits/timepoints, subgroup analyses, and statistical methods.
• Work closely with statistical programmers to ensure correct implementation of planned analyses.
• Review and respond to client/sponsor comments related to statistical documents and outputs.
• Participate in study team meetings and communicate statistical topics clearly in English.
• Ensure study-level statistical deliverables are accurate, consistent, and compliant with applicable regulatory and project requirements.

Requirements

• Master’s degree in Biostatistics or Statistics is required.
• 3+ years of experience as a Biostatistician in clinical trials, preferably 5+ years.
• Hands-on experience developing and reviewing Statistical Analysis Plans.
• Strong experience with study-level statistical documents and clinical trial deliverables.
• Experience reviewing and performing QC of Tables, Listings, and Figures.
• Good understanding of clinical trial methodology, endpoints, analysis populations, and common statistical methods.
• Ability to work independently in a CRO, pharma, biotech, or FSP environment.
• Strong written and spoken English.
• Good communication skills and ability to interact with project teams and clients.
• Preferred therapeutic area experience: ophthalmology and/or oncology.
• Understanding of CDISC/ADaM and statistical programming deliverables is a plus, but programming is not the primary responsibility.

Nice to Have

• PhD in Biostatistics or Statistics.
• Ophthalmology and/or oncology experience.
• Experience in regulatory submissions.
• Experience working directly with sponsors/clients.