Clinical Services: Senior Biostatistician

We are seeking a skilled and motivated Senior Biostatistician to join our fast-moving, collaborative environment focused on medical imaging and dermatology-based clinical development. In this role, you will support clinical studies through statistical planning, analysis, and reporting activities. The position requires strong technical expertise in statistics and SAS programming, with the ability to independently develop Statistical Analysis Plans (SAPs), execute and validate statistical analyses, and prepare statistical components of clinical study reports (CSRs). The right candidate can translate statistical outputs into clinically meaningful interpretations and communicate findings clearly to both technical and non-technical audiences.

Job Description

• Independently author Statistical Analysis Plans (SAPs), including definition of analysis populations, endpoints, statistical methods, missing data handling, and sensitivity analyses
• Provide statistical input into study protocols, including endpoint definition, sample size considerations, and methodological recommendations
• Independently develop, validate, and maintain SAS programs for analysis datasets, tables, listings, and figures (TLFs) in accordance with SAPs
• Perform statistical analyses aligned with SAPs and study objectives, ensuring accuracy, reproducibility, and compliance with regulatory expectations
• Prepare statistical sections of clinical study reports (CSRs), including interpretation of results
• Ensure analyses adhere to ICH and FDA guidance
• Collaborate cross-functionally with clinical, regulatory, data management, and medical writing teams to support study deliverables

Core Requirements

• Master’s degree in Biostatistics, Statistics, Mathematics or closely related quantitative discipline with at least 4 years of clinical research within a regulated environment (pharmaceutical, biotechnology, CRO, or medical device industry) or PhD with at least 2 years of relevant experience
• Demonstrated experience independently authoring Statistical Analysis Plans (SAPs), contributing to clinical study reports and regulatory documentation
• Proficiency in SAS, including validated code development, QC, and production of regulatory-grade TLFs
• Solid understanding of statistical methodology for clinical trials, including analysis population definitions, endpoint types, missing data, and multiplicity considerations
• Ability to communicate statistical results within the clinical study context
• Working knowledge of ICH E9/E9(R1) and FDA regulatory expectations
• Strong analytical skills with high attention to data integrity, reproducibility, and traceability
• Ability to manage projects or analysis within established timelines

Desired

• Experience with medical imaging or dermatology clinical studies
• Exposure to regulatory submission processes
• Experience contributing to peer-reviewed publications

Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation. Canfield offers comprehensive benefits to its eligible full-time employees. These include paid days off, medical, dental, and vision insurance, may be eligible for a discretionary bonus, and a 401(k) plan with employer match (currently set at 50%). The anticipated salary range for the position is $120,000.00-$160,000.00 annually. This is dependent upon consideration of multiple factors when determining a base salary such as a candidate’s experience, education, and current market conditions. If the role is eligible for full benefits, it will be discussed with you during the interview process. Canfield's imaging equipment leads the industry providing high-quality, registered, reproducible clinical images. This, together with proactive clinical image monitoring and a world class quality assurance regimen, sets the gold standard in image quality for clinical studies.