Lead Statistical Programmer - SDTM/ADaM & Submissions

Cytel; Hartford (CT); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client in Hartford. You will lead SAS programming for complex analyses, ensure SDTM/ADaM compliance, and drive regulatory submissions with minimal supervision.

You will provide expert technical support, review Define.xml, and mentor team members while collaborating with CROs, vendors, and FDA/other authorities. Strong communication and leadership are essential to align project goals.

Qualifications

• MS in biostatistics or a related field with substantial pharma experience (8+ years) or BS with 10+ years in pharma.
• Exceptional SAS programming skills for statistical programming procedures in a clinical setting.
• Extensive experience with CDISC SDTM/ADaM and Define.xml; familiarity with FDA/ICH regulations.

Responsibilities

• Provide technical and project leadership in SAS for clinical trial data analysis and reporting.
• Lead documentation to support data analysis and CDlSC data submission.
• Ensure compliance with SOPs and FDA/ICH regulations.
• Brief internal/external stakeholders on status, issues, and accomplishments.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH compliance

Leadership

Independent working

Communication skills

Define.xml review

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

SAS Macro language

BASE SAS

SAS/STAT

SAS/GRAPH

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client in Hartford. You will lead SAS programming for complex analyses, ensure SDTM/ADaM compliance, and drive regulatory submissions with minimal supervision.

You will provide expert technical support, review Define.xml, and mentor team members while collaborating with CROs, vendors, and FDA/other authorities. Strong communication and leadership are essential to align project goals.