Principal Statistical Programmer - SAS & R (Remote)

Rubyplay; Las Palmas de Gran Canaria; À distance; EUR 75 000 - 110 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a pharmaceutical client. You will implement reporting and analysis activities, oversee CRO programmers, and ensure data is delivered in a compliant, high-quality manner.

You will contribute to SDTM/ADaM development, study reports, regulatory submissions and exploratory analyses, while aligning with FDA/ICH guidelines and industry standards.

Qualifications

• 7+ years as Statistical Programmer in Biotech/Pharma
• CDISC SDTM/ADaM and Define.xml experience
• Exceptional SAS programming skills in clinical development
• Experience supporting regulatory submissions with FDA/ICH regulations
• Ability to work independently and lead CRO oversight

Responsabilités

• Generate SDTM, ADaM specs, datasets, review guides and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables and graphs
• Deliver high-quality SAS/R outputs tailored to clinical programs
• Oversee CROs' programming deliverables to meet timelines
• Support CSR, regulatory submissions, DSURs and exploratory analyses
• Adhere to FDA regulations for electronic submissions
• Contribute to standards for programming tools, outputs and macros
• Assist in CRF development, edit check specs and data validation plans
• Review/author data transfer specifications for external vendor data
• Collaborate with internal/external partners to meet project goals
• Review/write SOPs and work instructions for statistical programming practices

Connaissances

SAS programming

CDISC SDTM/ADaM

R

FDA/ICH regulations

Communication

Leadership

Independent work

Formation

Bachelor's degree in CS/Math/Statistics

Outils

SAS

R

Python

Unix/Linux

Git

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a pharmaceutical client. You will implement reporting and analysis activities, oversee CRO programmers, and ensure data is delivered in a compliant, high-quality manner.

You will contribute to SDTM/ADaM development, study reports, regulatory submissions and exploratory analyses, while aligning with FDA/ICH guidelines and industry standards.