Senior Statistical Programmer Lead — CDISC & Submissions

Cytel; Dover (DE); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel Inc. is seeking a Principal Statistical Programmer to work embedded with a major pharmaceutical client. You will lead SAS programming for complex clinical trial analyses and support regulatory submissions with minimal supervision.

Qualifications include an MS or BS in biostatistics with 8+ or 10+ years in pharma, expert SDTM/ADaM knowledge, Define.xml review, and strong communication. This role offers independent ownership and collaboration across CROs, FDA interactions, and internal teams.

Qualifications

• MS in biostatistics or related field with 8+ years in pharma
• BS in biostatistics or related field with 10+ years in pharma
• Exceptional SAS programming skills and SDTM/ADaM expertise
• CDISC standards, regulatory submissions experience, FDA/ICH familiarity
• Ability to work independently and lead projects

Responsibilities

• Leads SAS programming for complex trial analyses (Tables, Listings, Figures) and SDTM/ADaM datasets
• Develops and reviews documentation to support data analysis and CDISC submissions
• Ensures compliance with SOPs and regulatory regulations (FDA/ICH)
• Leads technical meetings with internal/external stakeholders (CROs, vendors, FDA/EMA)
• Performs QC of SAS code and reviews Define.xml and reviewer guides
• Maintains study documents and develops global utility programs

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH

Regulatory submissions

Leadership

Independent work

Education

MS in biostatistics

BS in biostatistics

Tools

SAS

Job description

Cytel Inc. is seeking a Principal Statistical Programmer to work embedded with a major pharmaceutical client. You will lead SAS programming for complex clinical trial analyses and support regulatory submissions with minimal supervision.

Qualifications include an MS or BS in biostatistics with 8+ or 10+ years in pharma, expert SDTM/ADaM knowledge, Define.xml review, and strong communication. This role offers independent ownership and collaboration across CROs, FDA interactions, and internal teams.