Hybrid Senior Statistical Programmer for Submissions

Clinical Resource Network (CRN); Princeton (NJ); Hybrid; USD 103,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Telehealth

ESOP

Commuter benefits

Job summary

Clinical Resource Network (CRN) in Princeton, NJ, is seeking a Senior Statistical Programmer to provide leadership across studies, SDTM/ADaM development, and TLFs. You will manage internal and external programming efforts, ensuring timely, regulatory-ready outputs for submissions.

Required 8+ years in statistical programming with CDISC, SAS expertise, and strong collaboration across Biostatistics, Data Management, and Regulatory Affairs.

Qualifications

• Master's degree in Statistics, Computer Science, Data Science, Health Sciences, Biostatistics, or related quantitative discipline.
• Minimum 8 years of statistical programming experience in pharma/biotech/life sciences.
• Expertise in CDISC standards (SDTM/ADaM/CDASH) and regulatory submission requirements.
• Experience supporting regulatory submissions, ISS/ISE, CSR programming, and regulatory responses.

Responsibilities

• Lead global programming activities for multiple studies with minimal supervision.
• Oversee external programming vendors and ensure quality, timelines, and regulatory compliance.
• Collaborate with cross-functional teams on SAP, CSR reviews, and data reconciliation.
• Support NDA/BLA/MAA submissions and related regulatory deliverables.
• Contribute to standards development and process improvements.

Skills

Leadership

Project Mgmt

Communication

Analytical thinking

Quality focus

Education

Master's degree in Statistics/CS/Data Science/Biostatistics

Tools

SAS

R

Python

Job description

Clinical Resource Network (CRN) in Princeton, NJ, is seeking a Senior Statistical Programmer to provide leadership across studies, SDTM/ADaM development, and TLFs. You will manage internal and external programming efforts, ensuring timely, regulatory-ready outputs for submissions.

Required 8+ years in statistical programming with CDISC, SAS expertise, and strong collaboration across Biostatistics, Data Management, and Regulatory Affairs.