Principal Statistical Programmer (SAS + R) – Remote

Hcl Technologies Limited; España; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated program with one of our pharmaceutical clients. You will develop SAS and R programs, create SDTM/ADaM datasets, and define outputs while ensuring regulatory compliance.

Reporting to the Director of Biostatistics and Programming, you will oversee CRO programmers, collaborate with cross-functional teams, and deliver high-quality analyses for regulatory submissions and study reports.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics (essential).
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma teams or similar.
• Exceptional SAS programming skills with experience in clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH guidelines.
• Experience supporting regulatory submissions and interaction with regulatory authorities.
• Ability to work independently with strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, and publications.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal and CRO partners to meet project goals.
• Contribute to SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC standards

Regulatory submissions

Communication skills

Leadership

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated program with one of our pharmaceutical clients. You will develop SAS and R programs, create SDTM/ADaM datasets, and define outputs while ensuring regulatory compliance.

Reporting to the Director of Biostatistics and Programming, you will oversee CRO programmers, collaborate with cross-functional teams, and deliver high-quality analyses for regulatory submissions and study reports.