Principal Statistical Programmer - SAS + R (Remote)

Toyota Tsusho Systems Corporation; Albacete; Remote; EUR 107,000 - 143,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) working remotely on sponsor-dedicated clinical programs. You will lead programming activities, generate SDTM/ADaM outputs, and oversee CRO deliverables in a fast-paced biostatistics environment.

You will apply extensive CDISC knowledge and FDA/ICH regulations, contribute to regulatory submissions, and mentor junior staff while delivering high-quality analyses and reports for multiple studies.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Biometrics.
• Exceptional SAS programming skills and experience in a clinical development environment.
• Extensive CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Must be able to work independently.
• Outstanding communication skills (written and verbal) and strong leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs for clinical development programs.
• Oversee CROs' statistical programming deliverables for multiple studies to ensure high-quality and timely delivery.
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.
• Follow FDA regulations that affect the reporting of clinical trial data, including GCP and e-submission guidelines.
• Contribute to creation, maintenance, and validation of standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal and external functions (CROs, vendors, partners) to meet timelines and goals.
• Provide review/author SOPs and Work Instructions related to statistical programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulation

Regulatory submissions

Communication skills

Leadership

Independent work

Education

Bachelor's degree in CS/Math/Statistics

Tools

SAS

R

Unix/Linux

Git

Python

Shiny

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) working remotely on sponsor-dedicated clinical programs. You will lead programming activities, generate SDTM/ADaM outputs, and oversee CRO deliverables in a fast-paced biostatistics environment.

You will apply extensive CDISC knowledge and FDA/ICH regulations, contribute to regulatory submissions, and mentor junior staff while delivering high-quality analyses and reports for multiple studies.