Principal Statistical Programmer (SAS & R) - Remote

Minsait; Barcelona; Remote; EUR 80,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a global pharmaceutical client. You will lead the programming efforts, focusing on SDTM/ADaM specifications, dataset creation, and complex reporting while collaborating with CROs and internal statisticians.

The role requires extensive SAS and R programming for clinical development programs, adherence to GCP and FDA electronic submission guidelines, and the ability to operate with minimal supervision in a

Qualifications

• Proven experience in statistical programming for clinical trials.
• Strong knowledge of SDTM/ADaM data standards and clinical reporting.
• Familiarity with FDA/ICH/GCP guidelines for electronic submissions.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, define.xml and reviewers' guides for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality programming outputs and collaborate with CROs and vendors.

Skills

Statistical programming

Clinical trial programming

FDA/ICH regulatory knowledge

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a global pharmaceutical client. You will lead the programming efforts, focusing on SDTM/ADaM specifications, dataset creation, and complex reporting while collaborating with CROs and internal statisticians.

The role requires extensive SAS and R programming for clinical development programs, adherence to GCP and FDA electronic submission guidelines, and the ability to operate with minimal supervision in a