Principal Statistical Programmer (SAS/R) – Remote

Infosys Consulting; Santiago de Compostela; Remote; EUR 70,000 - 90,000; Full time

Job summary

Infosys Consulting, in partnership with Cytel, is seeking a Senior/Principal Statistical Programmer for a sponsor-dedicated role. You will be fully remote, embedded with a leading pharmaceutical client, and supported by Cytel in delivering high-quality programming solutions.

The role focuses on implementing reporting and analysis activities across multiple studies, adhering to FDA guidelines and CDISC standards, and ensuring data integrity and timely delivery of outputs.

Qualifications

• Experience in statistical programming for clinical trials.
• Strong knowledge of FDA regulations and CDISC standards.
• Ability to work autonomously with minimal supervision.

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 using SAS and/or R
• Oversee CRO's statistical programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses
• Follow FDA regulations for reporting clinical trial data and guidelines for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specifications, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal and external functions to meet project timelines

Skills

SAS

R

Job description

Infosys Consulting, in partnership with Cytel, is seeking a Senior/Principal Statistical Programmer for a sponsor-dedicated role. You will be fully remote, embedded with a leading pharmaceutical client, and supported by Cytel in delivering high-quality programming solutions.

The role focuses on implementing reporting and analysis activities across multiple studies, adhering to FDA guidelines and CDISC standards, and ensuring data integrity and timely delivery of outputs.