Senior Statistical Programmer & CDISC Submissions Lead

Cytel; Boise (ID); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a leading pharmaceutical client in the United States. You will drive complex SAS analyses, support SDTM/ADaM datasets, and oversee regulatory submissions with autonomy.

In this role you will provide technical leadership, mentor team members, and coordinate with management and external partners to ensure project success while adhering to FDA/ICH regulations.

Qualifications

• MS or BS in biostatistics or related field with extensive pharma experience.
• Exceptional SAS programming skills for complex analyses and submissions.
• Expertise in CDISC standards (SDTM/ADaM/Define.xml) and regulatory expectations.

Responsibilities

• Lead SAS programming for tables, listings, figures and submissions.
• Develop and review SDTM/ADaM datasets and Define.xml.
• Provide project leadership and liaison with sponsors and vendors.
• Ensure compliance with SOPs and FDA/ICH/GCP regulations.
• Mentor junior programmers and conduct code reviews.
• Communicate status and milestones to management and stakeholders.

Skills

SAS programming

CDISC standards

Regulatory submissions

Project leadership

Communication skills

Education

MS in biostatistics

BS in biostatistics

Tools

SAS software

SAS Macro language

BASE SAS

SAS/GRAPH

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a leading pharmaceutical client in the United States. You will drive complex SAS analyses, support SDTM/ADaM datasets, and oversee regulatory submissions with autonomy.

In this role you will provide technical leadership, mentor team members, and coordinate with management and external partners to ensure project success while adhering to FDA/ICH regulations.