Principal Statistical Programmer – Remote, SAS & R Expert

Adiciona; País Vasco; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated setup. You will independently lead statistical programming activities across multiple studies, develop SDTM/ADaM datasets, and oversee CRO deliverables to ensure high-quality data and timely submissions.

Responsibilities include developing SAS/R programs, supporting regulatory submissions, and contributing to programming standards.

Qualifications

• At a minimum bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables, and graphs.
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs.
• Oversee CRO's statistical programming deliverables to ensure high quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Understand and follow FDA regulations affecting reporting of clinical trial data; ensure GCP and eSubmissions guidelines.
• Contribute to standards for programming tools, outputs, and macros; collaborate with multiple functions to meet timelines.
• Develop CRFs, edit check specs, and data validation plans; provide data transfer specifications for external vendors.
• Review and/or author SOPs and work instructions related to statistical programming practices.

Skills

Statistical programming

Clinical data analysis

Regulatory knowledge

Leadership / CRO oversight

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

ADaM/SDTM specifications

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated setup. You will independently lead statistical programming activities across multiple studies, develop SDTM/ADaM datasets, and oversee CRO deliverables to ensure high-quality data and timely submissions.

Responsibilities include developing SAS/R programs, supporting regulatory submissions, and contributing to programming standards.