Principal Statistical Programmer (SAS + R) – Remote

Infosys Consulting; Islas Baleares; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to join a pharmaceutical client-facing program. You will work independently, provide expert technical support, and oversee CRO programmers to ensure timely, high-quality deliverables.

You will generate SDTM/ADaM specifications and define.xml, develop SAS and R programs for complex tables, listings, graphs, and exploratory analyses, and contribute to study reports and regulatory submissions while adhering to FDA

Qualifications

• Experience delivering SDTM/ADaM specifications and datasets.
• Strong SAS programming skills for listings, tables, graphs.
• Experience overseeing CRO programmers.
• Knowledge of FDA regulations and electronic submissions.
• Ability to work independently 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 for multiple clinical studies
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR
• Understand and follow FDA regulations affecting reporting of clinical trial data
• Contribute to creation and validation of standards for programming tools and macros
• Develop CRFs, edit check specs, data validation plans
• Provide review and data transfer specifications for external vendors
• Collaborate with internal and external functions to meet timelines

Skills

SAS programming

R programming

SDTM/ADaM

Statistical programming

Quality assurance

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to join a pharmaceutical client-facing program. You will work independently, provide expert technical support, and oversee CRO programmers to ensure timely, high-quality deliverables.

You will generate SDTM/ADaM specifications and define.xml, develop SAS and R programs for complex tables, listings, graphs, and exploratory analyses, and contribute to study reports and regulatory submissions while adhering to FDA