Senior Statistical Programmer (SAS + R) – Remote

Thedoortalent; Oviedo; Remote; EUR 81,000 - 116,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (remote) to lead SAS and R programming for global clinical development programs. You will generate SDTM/ADaM artifacts, oversee CRO work, and support regulatory submissions with a focus on data quality and compliance.

The role requires independent work, strong communication, and leadership, with experience in CDISC standards and FDA/ICH guidelines for submissions.

Qualifications

• Bachelor's degree in CS, data science, mathematics or statistics preferred.
• 7+ years as Statistical Programmer in Biotech/Pharma/Clinical Development biometrics.
• Strong SAS programming and experience with CDISC standards.
• Experience with regulatory submissions and FDA/ICH guidelines.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml.
• Develop SAS programs to create datasets, tables, listings and graphs.
• Deliver high-quality SAS and R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions and DSURs.
• Follow GCP and FDA electronic submission guidelines.
• Develop and validate standards for programming tools and macros.
• Contribute to CRF development, data validation plans and data transfer specs.
• Collaborate with CROs, vendors and internal teams to meet goals.

Skills

SAS programming

R programming

CDISC standards

Regulatory submissions

Communication skills

Leadership

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

SAS

R

Python

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (remote) to lead SAS and R programming for global clinical development programs. You will generate SDTM/ADaM artifacts, oversee CRO work, and support regulatory submissions with a focus on data quality and compliance.

The role requires independent work, strong communication, and leadership, with experience in CDISC standards and FDA/ICH guidelines for submissions.