Senior Principal Statistical Programmer — Remote (SAS + R)

Jobgether

Huelva

Remote

EUR 108,000 - 161,000

Full time

6 days ago
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Job summary

Jobgether is seeking a Senior/Principal Statistical Programmer to lead complex programming for regulatory submissions in a remote capacity. You will generate SDTM and ADaM datasets, write robust SAS and R programs, and deliver high-quality analyses across multiple studies with minimal supervision.

You will oversee CRO programming deliverables, maintain study-specific standards, support study reports and DSURs, and ensure compliance with FDA guidelines and GCP throughout the data lifecycle.

Qualifications

  • Generate SDTM and ADaM specifications for multiple studies.
  • Develop SAS programs to generate datasets, listings, tables and graphs.
  • Deliver high-quality statistical programming results including SAS and/or R programs.

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 including developing, validating, and maintaining SAS and/or R programs
  • Participate in overseeing CRO\'s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet timelines
  • Support the preparation of clinical study reports, regulatory submissions, publications, and exploratory analyses
  • Understand and follow FDA regulations for reporting of clinical trial data and GCP

Skills

Statistical programming
SAS programming
R programming
Clinical data analysis
Regulatory knowledge
CRO oversight

Tools

SAS
R

Job description

Jobgether is seeking a Senior/Principal Statistical Programmer to lead complex programming for regulatory submissions in a remote capacity. You will generate SDTM and ADaM datasets, write robust SAS and R programs, and deliver high-quality analyses across multiple studies with minimal supervision.

You will oversee CRO programming deliverables, maintain study-specific standards, support study reports and DSURs, and ensure compliance with FDA guidelines and GCP throughout the data lifecycle.

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