Lead Statistical Programmer - SAS & R, Pharma, Remote

Deel; Granada; Remoto; EUR 108.000 - 161.000; Tempo pieno

Descrizione del lavoro

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) working remotely for a sponsor-dedicated role within a global pharmaceutical client.

You will lead independent programming tasks, develop SDTM/ADaM datasets and reports, and oversee CROs to ensure timely, high-quality deliverables across multiple studies. You will implement reporting and analysis activities for sponsor trials, support regulatory submissions, and ensure compliance with FDA regulations.

Competenze

• 7+ years of experience as a Statistical Programmer in biotech/pharmaClinical development biometrics
• Experience with CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interacting with regulatory authorities
• Ability to work independently
• Strong communication and leadership skills
• Experience overseeing CRO programmers and external vendors

Mansioni

• Generate SDTM/ADaM specifications, datasets, review guides and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables and graphs
• Deliver high-quality SAS/R programming outputs and maintain programs
• Oversee CRO deliverables to meet timelines and quality standards
• Support preparation of clinical study reports, regulatory submissions and publications
• Contribute to standards development for programming tools, outputs and macros
• Contribute to CRFs, edit check specs and data validation plans
• Provide data transfer specifications for external vendors
• Collaborate with internal and external partners to meet project goals
• Develop SOPs and work instructions for programming practices

Conoscenze

SAS programming

R programming

Statistical programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Formazione

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

Strumenti

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Define.xml

Descrizione del lavoro

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) working remotely for a sponsor-dedicated role within a global pharmaceutical client.

You will lead independent programming tasks, develop SDTM/ADaM datasets and reports, and oversee CROs to ensure timely, high-quality deliverables across multiple studies. You will implement reporting and analysis activities for sponsor trials, support regulatory submissions, and ensure compliance with FDA regulations.