Senior Principal Statistical Programmer (SAS + R) - Remote

trabajocantabria

Santa Cruz de Tenerife

Remote

EUR 70,000 - 100,000

Full time

4 days ago
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Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely on a sponsor-dedicated program embedded with a global pharmaceutical client. You will lead programming activities across SDTM/ADaM, datasets, listings, tables, and graphs with minimal supervision.

This role involves overseeing CRO programmers, supporting regulatory deliverables, and contributing to standards, CRFs, edit checks, and data validation plans while ensuring compliance with FDA guidance and GCP.

Qualifications

  • Lead SDTM/ADaM specifications and create datasets and define.xml for multiple studies
  • Develop SAS programs to generate datasets, complex listings, tables and graphs
  • Deliver high-quality statistical programming results and validate SAS/R programs tailored to trials
  • Oversee CRO programming deliverables to ensure timelines and quality

Responsibilities

  • Generate SDTM, ADaM specifications, datasets, reviewer's guides 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 programming deliverables to ensure high-quality outputs and timelines
  • Support preparation of regulatory submissions and exploratory analyses
  • Follow FDA regulations and GCP for electronic submissions
  • Contribute to standards for programming tools, outputs, and macros
  • Participate in development of CRFs and data validation plans
  • Provide review

Skills

SAS
R
Clinical programming

Tools

SDTM
ADaM
define.xml

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely on a sponsor-dedicated program embedded with a global pharmaceutical client. You will lead programming activities across SDTM/ADaM, datasets, listings, tables, and graphs with minimal supervision.

This role involves overseeing CRO programmers, supporting regulatory deliverables, and contributing to standards, CRFs, edit checks, and data validation plans while ensuring compliance with FDA guidance and GCP.

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