Senior Principal Statistical Programmer - SDTM/ADaM Leader

Cytel; Juneau (AK); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a global pharmaceutical client. You will lead SAS programming for complex trial analyses, support SDTM/ADaM submissions, and ensure regulatory compliance.

You will influence project directions, brief management on progress, and collaborate with IS, CROs, and vendors. The role requires extensive SAS expertise and leadership in a fast-paced environment.

Qualifications

• MS in biostatistics or a related field with 8+ years in pharma, or BS with 10+ years in pharma.
• Exceptional SAS programming skills for clinical development and SDTM/ADaM.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml).
• Proficient in SAS language, macros, BASE SAS, SAS/STAT, SAS/GRAPH.
• Experience supporting regulatory submissions with FDA/ICH.
• Ability to work independently and lead projects.
• Excellent written and verbal communication and leadership skills.
• Experience with regulatory submissions (BLAs/MAAs) is a plus.

Responsibilities

• Provide technical and project leadership in SAS programs for complex clinical trial data.
• Create, review, and approve documentation for data analysis and CDISC submissions.
• Ensure compliance with SOPs and FDA/ICH regulations.
• Lead technical meetings with internal and external stakeholders (CROs, vendors, FDA).
• Perform QC of advanced SAS code and validate datasets and outputs.
• Review Define.xml and prepare reviewer guides for SDTM/ADaM datasets.
• Maintain study documents per standard processes.
• Develop and document global utility programs and tools.

Skills

SAS programming

CDISC SDTM/ADaM

SAS Macro language

BASE SAS

SAS/STAT

SAS/GRAPH

Regulatory submissions

Clinical trial reporting

Leadership

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

Define.xml

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a global pharmaceutical client. You will lead SAS programming for complex trial analyses, support SDTM/ADaM submissions, and ensure regulatory compliance.

You will influence project directions, brief management on progress, and collaborate with IS, CROs, and vendors. The role requires extensive SAS expertise and leadership in a fast-paced environment.