Principal Statistical Programmer

Clinical Outcomes Solutions

Principal Statistical Programmer focusing on oncology clinical development for pharmaceutical innovation. Working independently with minimal supervision and leading statistical programming efforts.

Posted 6/11/2026full-timeRemote • California • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Meetings and communications
Generate SDTM and ADaM specifications
Generate & QC assigned dataset domains
Support submission activities
Generate TLFs (patient profile, interim analysis, annual summary report, final CSR)
Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s)
Handling Data transfers to sponsor (or other designee)
Publication support
Ad hoc tasks/activities requested by sponsor
Writing SAS macros and other utilities and tools
Reviewing documents/specifications/output created by sponsor’s Partner CROs
Maintenance of associated tracking and validation documentation

Requirements

What you’ll need

At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
8+ years of experience as a Statistical Programmer in clinical Development environment
Excellent SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
Prior working experience with Oncology studies
Must be able to work independently
Outstanding communication skills (written and verbal) and strong leadership skills

Benefits

Comp & perks

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SAS programmingstatistical programming proceduresCDISC standardsSDTMADaMDefine.xmlstatistical analysisdata validationdata transferQC dataset domains

Soft Skills

communication skillsleadership skillsindependent workcollaborationproblem-solvingattention to detailtime managementadaptabilitycritical thinkinginterpersonal skills