Lead Statistical Programmer — Global Trials & Submissions

ClinChoice; España; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

ClinChoice is seeking a Senior/Principal Statistical Programmer to lead programming across multiple studies in oncology, rare disease, or neuroscience. You will work with statisticians, data management, and cross-functional teams to ensure timely, high-quality outputs and to support regulatory submissions.

The role requires strong SAS expertise, SDTM/ADaM knowledge, and mentoring capabilities, with responsibilities spanning from study start-up to database lock and submission readiness.

Qualifikationen

• Strong proficiency in SAS programming in pharma/CRO context.
• Solid understanding of CDISC SDTM/ADaM standards and workflows.
• Hands-on SDTM/ADaM specification, development and programming.
• Experience with TFL programming and reporting for clinical trials.
• Experience supporting regulatory submissions and data standards."],
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Aufgaben

• Serve as lead statistical programmer for multiple studies, ensuring high-quality, timely delivery of programming activities.
• Lead and execute programming across trials from start-up through database lock, reporting, and submissions.
• Ensure consistency, quality, and executional excellence across programming deliverables.
• Provide technical oversight for outsourced programming to meet quality, budget, and timelines.
• Develop, review, and validate TLFs, SDTM/ADaM datasets, and Define-XML.

Kenntnisse

SAS programming

CDISC standards (SDTM/ADaM)

TFL programming

Regulatory submissions

Programming leadership

Mentoring others

Clinical trials experience

Quality focus

Ausbildung

Bachelor or MSc in Statistics or related field

Tools

SAS

Jobbeschreibung

ClinChoice is seeking a Senior/Principal Statistical Programmer to lead programming across multiple studies in oncology, rare disease, or neuroscience. You will work with statisticians, data management, and cross-functional teams to ensure timely, high-quality outputs and to support regulatory submissions.

The role requires strong SAS expertise, SDTM/ADaM knowledge, and mentoring capabilities, with responsibilities spanning from study start-up to database lock and submission readiness.