Principal Statistical Programmer (SAS + R) – Remote

Stratesys Group; Madrid; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated pharmaceutical client, backed by Cytel.

You will drive reporting and analysis activities across multiple studies and mentor CRO programmers to ensure high-quality data outputs. We require 7+ years of biostatistics programming experience, deep CDISC standards knowledge (SDTM/ADaM/Define.xml), and strong communication and leadership skills to support regulatory submissions and

Qualifications

• Bachelor's degree in a relevant field
• 7+ years of experience as Statistical Programmer in Biotech/Pharma
• Exceptional SAS programming skills and SDTM/ADaM expertise
• Extensive CDISC standards knowledge (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and liaison with regulatory authorities
• Ability to work independently and lead CRO programming efforts
• Strong communication and leadership skills

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables and graphs
• Deliver high-quality SAS and R programs tailored to clinical development needs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions and exploratory analyses
• Adhere to FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit checks, and data validation plans
• Provide data transfer specifications for external vendor data
• Collaborate with internal/external partners to meet project goals
• Review and/or author SOPs and Work Instructions related to statistical programming

Connaissances

SAS programming

R programming

Independent work

Leadership

Communication

Formation

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Outils

SAS

R

Unix/Linux

CDISC SDTM/ADaM

Define.xml

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated pharmaceutical client, backed by Cytel.

You will drive reporting and analysis activities across multiple studies and mentor CRO programmers to ensure high-quality data outputs. We require 7+ years of biostatistics programming experience, deep CDISC standards knowledge (SDTM/ADaM/Define.xml), and strong communication and leadership skills to support regulatory submissions and