Principal Statistical Programmer (Remote) — SAS & R Expert

Ag Planning Events Sl; Tarragona; Remote; EUR 85,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client. The role focuses on delivering SDTM/ADaM datasets, complex listings, tables, and graphs using SAS and R, with CRO oversight and strict adherence to regulatory standards.

The position reports to the Director, Biostatistics and Programming within Cytel and involves independent work with minimal supervision, contributing to clinical study reports and regulatory submissions for global

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 programming results including developing, validating, and maintaining SAS and/or R programs
• Oversee CRO's statistical programming deliverables to meet timelines
• Assist in preparing clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses
• Understand FDA regulations affecting reporting of clinical trial data (GCP, eSubmissions)
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet project timelines and goals
• Provide review and/or SOPs/Work Instructions related to statistical programming practices

Skills

SAS

R

Clinical trials

SDTM

ADaM

GCP

Tools

SAS

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client. The role focuses on delivering SDTM/ADaM datasets, complex listings, tables, and graphs using SAS and R, with CRO oversight and strict adherence to regulatory standards.

The position reports to the Director, Biostatistics and Programming within Cytel and involves independent work with minimal supervision, contributing to clinical study reports and regulatory submissions for global