Senior Principal Statistical Programmer (SAS + R) — Remote

Farmacia Con Atención Al Usuario Personalizada

Badajoz

Remote

EUR 60,000 - 85,000

Full time

3 days ago
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Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a major pharmaceutical client. You will independently manage programming across SDTM/ADaM, define.xml, listings and tables, and guide CROs to ensure high-quality deliverables.

Responsibilities include regulatory submissions support, clinical study reports, DSURs, and exploratory analyses, with strong emphasis on FDA/ICH guidelines and CDISC standards. Strong leadership and communication are essential.

Qualifications

  • Minimum bachelor's degree in CS, data science, mathematics, or statistics.
  • 7+ years of Statistical Programmer experience in Biotech/Pharma.
  • Expert SAS programming skills with CDISC SDTM/ADaM and Define.xml.
  • Experience with regulatory submissions and FDA/ICH guidelines.

Responsibilities

  • Generate SDTM/ADaM specifications, datasets, reviewer's guide, and define.xml.
  • Develop SAS programs for datasets, listings, tables, and graphs.
  • Deliver high-quality SAS/R programs for clinical programs.
  • Oversee CRO programming deliverables to meet timelines.
  • Support preparation of CSRs, regulatory submissions, DSURs, and analyses.
  • Collaborate with CROs, vendors, and clinical partners.

Skills

SAS programming
CDISC (SDTM/ADaM)
R
Python
Leadership

Education

Bachelor's degree in Computer Science, Mathematics, Statistics or Data Science

Tools

SAS
R
Python
Shiny
Unix/Linux
Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a major pharmaceutical client. You will independently manage programming across SDTM/ADaM, define.xml, listings and tables, and guide CROs to ensure high-quality deliverables.

Responsibilities include regulatory submissions support, clinical study reports, DSURs, and exploratory analyses, with strong emphasis on FDA/ICH guidelines and CDISC standards. Strong leadership and communication are essential.

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