Principal Statistical Programmer (SAS/R) Remote

Biodist Sa De Cv; Guadalajara; Remote; EUR 108,000 - 161,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated program, working remotely with one global pharma client.

You will lead complex programming for SDTM/ADaM, generate reports, and oversee CRO deliverables to ensure high-quality submissions. In this role you will implement CDISC standards, support regulatory submissions, and collaborate with statisticians, data managers and vendors while maintaining strict GCP and FDA guidelines.

Qualifications

• 7+ years of statistical programming in biotech/pharma.
• Exceptional SAS programming and CDISC SDTM/ADaM expertise.
• Experience with regulatory submissions and FDA/ICH guidelines.
• Ability to work independently and lead CROs.
• Strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewers' guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality results with SAS and/or R tailored to clinical programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external data.
• Collaborate with CROs, vendors, and clinical partners to meet goals.
• Prepare SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC standards

Regulatory submissions

Leadership

Communication

Education

Bachelor's degree in CS/Math/Stats

Tools

SAS

Python

Unix/Linux

Git

Shiny

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated program, working remotely with one global pharma client.

You will lead complex programming for SDTM/ADaM, generate reports, and oversee CRO deliverables to ensure high-quality submissions. In this role you will implement CDISC standards, support regulatory submissions, and collaborate with statisticians, data managers and vendors while maintaining strict GCP and FDA guidelines.