Senior Biostatistician

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

Skills

Strong technical expertise in statistics and SAS programming.

Benefits

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.

Pay

$120,000.00 - $160,000.00 annually

Schedule

N/A