Biostatistician II Job at canfield scientific

Biostatistician II

canfield scientific

Location:
United States of America

Category:
Research and Development

Contract Type:
Not provided

Salary:

100000.00 - 120000.00 USD / Year

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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 Responsibility:

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

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

Nice to have:

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

What we offer:

Paid days off
Medical, dental, and vision insurance
May be eligible for a discretionary bonus
401(k) plan with employer match (currently set at 50%)

Additional Information:

Job Posted:
March 19, 2026

Employment Type:

Fulltime

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