Principal Statistical Programmer, SAS & R — Remote

Deel; Tarragona; A distancia; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. This role involves advising CROs, developing SAS and R programs, and ensuring SDTM/ADaM compliance under FDA/ICH guidelines.

The candidate will lead programming efforts, contribute to study reports, regulatory submissions, and DSURs while maintaining high data quality and adherence to project timelines.

Formación

• Bachelor's degree required in computer science, data science, mathematics or statistics.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• SAS programming skills with SDTM/ADaM/Define.xml experience.
• Experience supporting regulatory submissions and FDA/ICH regulation.
• Ability to work independently.
• Strong communication and leadership skills.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, define.xml files for multiple studies.
• Develop SAS programs for datasets, complex listings, tables and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR.
• Follow FDA regulations and GCP 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 vendors.
• Collaborate with CROs, vendors to meet timelines.
• Review and/or author SOPs and Work Instructions.

Conocimientos

SAS programming

R programming

CDISC knowledge

Leadership

Communication

Independent work

Educación

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

Herramientas

SAS

R

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. This role involves advising CROs, developing SAS and R programs, and ensuring SDTM/ADaM compliance under FDA/ICH guidelines.

The candidate will lead programming efforts, contribute to study reports, regulatory submissions, and DSURs while maintaining high data quality and adherence to project timelines.