Remote Principal Statistical Programmer (SAS + R)

Quironprevencion; España; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client. You will lead SAS and R programming for SDTM/ADaM, supervise CRO deliverables, and support regulatory submissions.

The role requires deep statistical programming expertise and knowledge of FDA electronic submission guidelines. The position focuses on multiple therapeutic areas in clinical development, offering autonomy and ownership with high-quality output and adherence to GCP and FDA

Qualifications

• Senior statistical programmer with clinical development experience.
• Experience with SAS and R programming.
• Knowledge of FDA regulations for electronic submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results including SAS and/or R programs
• Oversee CRO's programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, DSUR, and exploratory analyses
• Understand and follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review

Skills

Independent work

Clinical data analysis

Biostatistics knowledge

Tools

SAS

R

Job description

Cytel is seeking a Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client. You will lead SAS and R programming for SDTM/ADaM, supervise CRO deliverables, and support regulatory submissions.

The role requires deep statistical programming expertise and knowledge of FDA electronic submission guidelines. The position focuses on multiple therapeutic areas in clinical development, offering autonomy and ownership with high-quality output and adherence to GCP and FDA