Lead Statistical Programmer for Clinical Trials Submissions

Cytel; Santa Fe (NM); On-site; USD 140,000 - 180,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer to work embedded with a pharmaceutical client, leading SAS programming for complex trials and regulatory submissions. The role emphasizes independence, project leadership, and collaboration with FDA/ICH regulators. Strong CDISC expertise and Define.xml experience are required.

The position involves working with cross-functional teams to ensure compliant data analysis and timely submissions, with Cytel providing ongoing training and support.

Qualifications

• MS in biostatistics or related field with 8+ years in pharma, or BS with 10+ years in pharma.
• Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory submissions (FDA/ICH).
• Proven expert in SAS language and procedures used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
• Experience supporting regulatory submissions and interacting with FDA or global authorities.
• Ability to work independently and lead initiatives.
• Strong written and oral communication and leadership skills.

Responsibilities

• Lead SAS programming efforts for Tables, Listings, and Figures and SDTM/ADaM datasets.
• Create, review and approve documentation to support data analysis and submissions.
• Ensure compliance with SOPs and FDA/ICH/GCP regulations.
• Lead technical meetings with internal/external partners (IS, CROs, vendors, FDA/EMA).
• Perform quality control on advanced SAS code and outputs.
• Review define.xml and develop reviewers guides for SDTM/ADaM datasets.
• Maintain study documents per standard process.
• Program, test, and document global utility programs and tools.

Skills

SAS programming

CDISC standards

Regulatory submissions

Independent work

Communication

Project leadership

FDA/ICH knowledge

Presentation skills

Education

MS in Biostatistics

BS in Biostatistics

Tools

SAS Macro language

BASE SAS

SAS/STAT

SAS/GRAPH

Define.xml

Job description

Cytel seeks a Principal Statistical Programmer to work embedded with a pharmaceutical client, leading SAS programming for complex trials and regulatory submissions. The role emphasizes independence, project leadership, and collaboration with FDA/ICH regulators. Strong CDISC expertise and Define.xml experience are required.

The position involves working with cross-functional teams to ensure compliant data analysis and timely submissions, with Cytel providing ongoing training and support.