Senior Clinical Statistical Programmer (Remote)

Spectraforce Technologies, Inc.; Florham Park (NJ); On-site; USD 96,000 - 152,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Senior Statistical Programmer contractor to provide expert-level SAS programming across clinical studies, regulatory submissions, and exploratory analyses.

You will develop and validate SDTM/ADaM datasets and TLFs, while ensuring QC and regulatory compliance. The role requires 10+ years of hands-on programming experience, strong communication, and the ability to manage multiple projects in a fast-paced environment.

Qualifications

• 10+ years of hands-on statistical programming in pharma/biotech/CRO.
• GCP/ICH guidelines and FDA regulatory requirements; NDA/MAA/BLA experience preferred.
• Strong SAS programming and macro development; R or Python a plus.
• CDISC SDTM/ADaM Define.xml knowledge and submission-ready datasets.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent written and verbal communication skills.

Responsibilities

• Provide expert-level support for statistical programming across clinical and device studies, regulatory submissions, and exploratory analyses.
• Perform rigorous QC of programming deliverables to ensure regulatory compliance.
• Collaborate with biostatistics, data management and cross-functional teams for trials, FDA submissions and publications.
• Develop, validate, and maintain departmental standard macros and templates.
• Write and validate SAS programs for SDTM/ADaM datasets and TLFs.
• Review data specifications for SDTM/ADaM datasets and contribute to innovative programming strategies.
• Ensure adherence to SOPs and regulatory requirements.

Skills

SAS programming

CDISC SDTM/ADaM

Macro development

Regulatory submissions knowledge

Project management

Communication skills

CSR/ISS/ISE experience

Tools

SAS

R/Python

Job description

Spectraforce Technologies, Inc. seeks a Senior Statistical Programmer contractor to provide expert-level SAS programming across clinical studies, regulatory submissions, and exploratory analyses.

You will develop and validate SDTM/ADaM datasets and TLFs, while ensuring QC and regulatory compliance. The role requires 10+ years of hands-on programming experience, strong communication, and the ability to manage multiple projects in a fast-paced environment.