Programador Estadístico Sénior (SAS+R) Remoto

Colegio De Farmacéuticos De Cádiz; Jerez de la Frontera; A distancia; EUR 107.000 - 152.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated remote program.

You will develop SAS and R solutions for global clinical studies, author data specifications, and drive high-quality reporting aligned with CDISC standards. In this role you will oversee CRO programming activities, support regulatory submissions, and collaborate with cross-functional teams to ensure timely delivery while upholding GCP and FDA guidelines.

Formación

• Bachelor's degree in CS/Data Science/Math/Stats
• 7+ years experience as Statistical Programmer in Biotech/Pharma
• Exceptional SAS programming skills
• Extensive CDISC (SDTM/ADaM/Define.xml) and FDA/ICH knowledge
• Experience supporting regulatory submissions
• Ability to work independently
• Strong communication and leadership skills

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs for datasets, complex listings, tables and graphs
• Oversee CRO programmers to ensure high-quality deliverables and timelines
• Support clinical study reports, regulatory submissions, DSURs, and exploratory analyses
• Understand and apply FDA regulations and GCP guidelines for reporting
• Create, maintain, and validate programming standards, tools, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide data transfer specifications for external vendor data
• Collaborate with CROs, vendors, and internal partners to meet project goals
• Draft SOPs and Work Instructions for programming practices

Conocimientos

SAS programming

CDISC standards

Statistical programming

Regulatory submissions

Leadership

Communication skills

Independent work

Educación

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

Herramientas

R

Define.xml

SDTM

ADaM

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated remote program.

You will develop SAS and R solutions for global clinical studies, author data specifications, and drive high-quality reporting aligned with CDISC standards. In this role you will oversee CRO programming activities, support regulatory submissions, and collaborate with cross-functional teams to ensure timely delivery while upholding GCP and FDA guidelines.