Senior/Principal Statistical Programmer (SAS + R) - Remote

Empresa De Gestión Y Selección; Brea de Aragón; Teletrabalho; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work on sponsor projects embedded with a pharmaceutical client. You will lead SAS programming and collaborate with CROs to ensure data quality for submissions.

You will implement SDTM/ADaM, develop datasets and tables, and support regulatory submissions while adhering to FDA/ICH and GCP guidelines. Strong communication and leadership are required.

Qualificações

• Bachelor's or higher in CS/Math/Stats or related field.
• 7+ years as Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming with CDISC standards.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewers guide and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical development.
• Oversee CRO programming deliverables to meet timelines.
• Support clinical study reports and regulatory submissions.
• Follow FDA/ICH regulations and GCP.
• Create/maintain standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, data validation plans.
• Review/author data transfer specs for external data.
• Collaborate with CROs, vendors and partners to meet goals.
• Contribute SOPs and Work Instructions for statistical programming.

Conhecimentos

SAS programming

Communication skills

Leadership

Independent work

Formação académica

Bachelor's degree in Computer Science

Bachelor's degree in Data Science

Bachelor's degree in Mathematics

Bachelor's degree in Statistics

Ferramentas

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

CDISC SDTM/ADaM

Descrição da oferta de emprego

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work on sponsor projects embedded with a pharmaceutical client. You will lead SAS programming and collaborate with CROs to ensure data quality for submissions.

You will implement SDTM/ADaM, develop datasets and tables, and support regulatory submissions while adhering to FDA/ICH and GCP guidelines. Strong communication and leadership are required.