Clinical Services: Senior Biostatistician

Job Description

Independently author Statistical Analysis Plans (SAPs), including definition of analysis populations, endpoints, statistical methods, missing data handling, and sensitivity analyses.
Promote statistical input into study protocols, including endpoint definition, sample size considerations, and methodological recommendations.
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.
• Able 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.
• Able 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.

Qualifications

• 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).
• PhD with at least 2 years of relevant experience.

Skills

• Statistical Analysis Plans (SAPs)
• Study Protocols
• SAS Programming
• Medical Imaging or Dermatology Clinical Studies
• Regulatory Submission Processes
• Peer-Reviewed Publications

Benefits

• Paid days off
• Medical, dental, and vision insurance
• Discretionary bonus
• 401(k) plan with employer match (currently set at 50%)

Pay

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.

Schedule

Full-time

Canfield Scientific, Inc.

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.

Company Overview

Canfield Scientific, Inc. offers comprehensive benefits to its eligible full-time employees, including 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%).

Company Culture

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.