Contractor – Principal Statistical Programmer

Scorpion Therapeutics; New York (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a Principal Statistical Programmer to provide expert-level SAS programming support for clinical trial data analysis and reporting in line with SAPs, ICH guidelines, and FDA requirements.

You will lead production of tables, listings, and figures for regulatory submissions and HEOR analyses, collaborating with statisticians, data managers, and cross-functional teams across multiple drug programs. Oncology experience is essential.

Qualifications

• At least 8 years relevant experience (5+ years may be considered); Bachelor’s degree.
• Oncology experience required; leukemia experience preferred.
• Excellent communication to non-technical colleagues and ability to manage multiple projects with aggressive timelines.
• Advanced SAS knowledge; familiar with WHO, MedDRA coding dictionaries; expert in CDISC.
• Knowledge of medical/statistical terminology; proficient with Windows, Word, and Excel.

Responsibilities

• Produce tables, listings, and figures and CRF tabulations (including ISS/ISE).
• Primary programmer for regulatory, commercial, ad hoc, biomarker, and HEOR analyses.
• Review Standards Artifacts and Processes (SAPs, Data Validation Plans, eCRFs) and provide comments.
• Troubleshoot and quality-review complex SAS programs and document work.
• Follow FDA regulations affecting clinical trial data reporting.

Skills

SAS programming

Regulatory knowledge

CDISC

Statistical terminology

Communication skills

Education

Bachelor’s degree

Tools

SAS

Microsoft Word/Excel

WHO/MedDRA coding dictionaries

CDISC standards

Windows

Job description

The Principal Statistical Programmer will provide expert-level hands-on programming support and technical expertise to develop, maintain, validate, and execute SAS programs that access, visualize, analyze, and report clinical trial data in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. Supports statistical programming for in-house and outsourced clinical trials, commercial requests, HEOR analyses, pooled analyses (ISE/ISS), biomarker analyses, and ad hoc analyses.

Key Responsibilities:

• Support study leads and take ownership of multiple deliverables across drug programs and platforms.
• Act as an integral project team member, collaborating with vendors, biostatisticians, data managers, and cross-functional teams.
• Primary role for production of tables, listings, and figures, and CRF tabulations (including ISS/ISE).
• Serve as primary programmer for regulatory, commercial, ad hoc, biomarker, and HEOR analyses.
• Review critical Standards Artifacts and Processes (e.g., SAPs, Data Validation Plans, eCRFs) and provide comments.
• Troubleshoot and provide quality review of complex SAS programs; follow good programming practices and document programs.
• Understand and follow FDA regulations affecting clinical trial data reporting.

Desired Experience/Education and Skills:

• At least 8 years relevant experience (5+ years may be considered); Bachelor’s degree.
• Oncology experience required; leukemia experience preferred.
• Excellent communication to non-technical colleagues; completed large/complex projects; handle multiple projects with aggressive timelines.
• Advanced/excellent SAS knowledge; familiarity with coding dictionaries (WHO, MedDRA); expert in CDISC.
• Knowledge of medical/statistical terminology; capable with Windows, Word, and Excel.