Job Description

We are seeking a skilled and motivated Biostatistician II to join our fast-paced, collaborative environment and applying statistical expertise to advance clinical research and study objectives. The ideal candidate will support clinical studies by implementing predefined analyses, contributing to Statistical Analysis Plans (SAPs), and assisting with study-level statistical design discussions. The right candidate is a proactive professional with strong analytical skills, attention to detail, and the ability to communicate complex statistical findings clearly to both technical and non-technical audiences. They will work collaboratively across teams, while also managing assigned analyses or workstreams independently.

Job Description

• Contribute to the development and authoring of Statistical Analysis Plans (SAPs), including drafting key sections (analysis populations, endpoints, missing data handling, sensitivity analyses) under senior statistical guidance
• Support protocol development through input on endpoint definitions, statistical methodology, and sample size considerations
• Independently develop, validate, and maintain statistical programs for assigned analyses in SAS
• Participate in data review activities, and perform data quality checks in collaboration with data management
• Perform and interpret statistical analyses aligned with study objectives and regulatory requirements
• Draft statistical sections of clinical study reports, TLF shells, and other regulatory-facing documents, with review from senior statisticians
• Ensure analyses adhere to ICH and FDA guidance, following established departmental standards and QC procedures
• Collaborate cross-functionally with clinical, regulatory, data management, and medical writing teams to support study deliverables
• Contribute to process improvement, template development, and standardization initiatives

Core Requirements

• Master's degree in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
• 3-5 years of experience in clinical research within a regulated environment including contributing to Statistical Analysis Plans (SAPs) and drafting sections under senior statistical oversight
• Demonstrated proficiency in SAS, including development of validated analysis programs and implementation of standard QC procedures
• Solid understanding of statistical methodology for clinical trials, including analysis population definitions, common endpoint types, handling of missing data, and basic multiplicity considerations
• Working knowledge of ICH E9/E9(R1) principles and general FDA regulatory expectations
• Ability to implement predefined analyses independently and contribute to statistical design discussions with appropriate supervision and manage assigned studies or analysis workstreams within established timelines
• Experience contributing to statistical sections of CSRs, TLF specifications, and other regulatory-facing documents

Desired

• Experience with medical imaging or dermatology clinical studies, including image-derived endpoints, exposure to regulatory submission processes
• Familiarity with longitudinal/mixed models, test-retest reliability, and reproducibility analyses, and with statistical programming in SAS or R for clinical trial reporting in a regulated environment

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 $100,000.00-$120,000.00 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.

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