Principal Statistical Programmer (SAS/R) – Remote

Direction Design And Print; Málaga; À distance; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote engagement with one of our pharmaceutical clients. You will work independently, manage programming deliverables, and support regulatory submissions while collaborating with CROs and cross-functional teams.

You will develop SDTM/ADaM datasets and complex analyses, ensuring high-quality outputs and adherence to FDA guidelines. This role offers autonomy and a critical impact on trial data analyses.

Qualifications

• Senior-level, independent statistical programming role in pharmacology
• Experience delivering SDTM/ADaM and regulatory submissions
• Ability to oversee CRO programmers and ensure data quality

Responsabilités

• Generate SDTM/ADaM specifications and datasets
• Develop SAS programs for datasets, tables, listings and figures
• Deliver SAS/R programs for clinical development programs
• Oversee CROs to meet timelines and quality standards
• Support clinical study reports, regulatory submissions, publications
• Follow FDA/ICH guidelines for electronic submissions
• Contribute to standards, CRFs, edit checks, and data validation plans
• Collaborate with internal/external teams to meet project goals
• Draft SOPs and work instructions related to programming practices

Connaissances

Statistical programming

Clinical trial analysis

Outils

SAS

R

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote engagement with one of our pharmaceutical clients. You will work independently, manage programming deliverables, and support regulatory submissions while collaborating with CROs and cross-functional teams.

You will develop SDTM/ADaM datasets and complex analyses, ensuring high-quality outputs and adherence to FDA guidelines. This role offers autonomy and a critical impact on trial data analyses.