Clinical Trials Lead: Senior Statistical Programmer

Katalyst CRO; Paramus (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks a Senior Manager in Statistics in Paramus, NJ, to lead statistical activities across clinical trials from protocol through final study report and regulatory filings. The role requires expert SAS skills, strong knowledge of ICH/CDISC and FDA guidelines, and leadership of CRO statisticians and programmers.

The role emphasizes collaboration with cross-functional teams, timely delivery, and oversight of statistical programming and data quality.

Qualifications

• Proficiency with SAS software.
• Familiarity with ICH, CDISC, and FDA guidelines.
• Strong organizational and time-management skills.
• Ability to lead CRO statisticians and programmers.

Responsibilities

• Review protocols and design study elements including sample size calculations and analysis methods.
• Review CRFs, database design, and edit check specifications.
• Monitor study conduct and ensure quality surveillance.
• Prepare or review SAPs and specifications for data derivation.
• Collaborate with statisticians, programmers, and data managers to resolve data quality issues.
• Provide statistical support for analyses and validation.
• Review study reports and regulatory documents.
• Contribute to responses to health authorities.

Skills

SAS

ICH Guidelines

CDISC Data Structures

FDA Guidelines

Communication

Leadership

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Job description

Katalyst CRO seeks a Senior Manager in Statistics in Paramus, NJ, to lead statistical activities across clinical trials from protocol through final study report and regulatory filings. The role requires expert SAS skills, strong knowledge of ICH/CDISC and FDA guidelines, and leadership of CRO statisticians and programmers.

The role emphasizes collaboration with cross-functional teams, timely delivery, and oversight of statistical programming and data quality.