Senior Principal Statistical Programmer (SAS + R) - Remote

Viamed Salud; Logroño; Remote; EUR 80,000 - 105,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor team in the pharmaceutical sector. The role involves independent work, CRO oversight, and delivering SDTM/ADaM specifications and Define.xml across multiple studies.

Responsibilities include developing SAS and R programs, supporting regulatory submissions, and ensuring adherence to FDA/ICH guidelines. Strong leadership and communication are essential for success.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team.
• Exceptional SAS programming skills and expertise in development and implementation of statistical programming procedures and processes.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, trial methodologies, and FDA/ICH regulations.
• Experience supporting regulatory submissions, interacting with FDA and/or global authorities.
• Must be able to work independently.
• Outstanding communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and Define.xml for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables, and graphs.
• Deliver high-quality programming results including developing, validating, and maintaining SAS and/or R programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Follow FDA regulations affecting reporting of clinical trial data (GCP, eSubmissions).
• Develop and validate standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide reviews/author data transfer specs for external vendor data.
• Collaborate with internal/external functions to meet timelines.
• Provide reviews/author SOPs and Work Instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions

Leadership

Independent work

Communication skills

Education

Bachelor's degree in computer science/data science/mathematics/statistics

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor team in the pharmaceutical sector. The role involves independent work, CRO oversight, and delivering SDTM/ADaM specifications and Define.xml across multiple studies.

Responsibilities include developing SAS and R programs, supporting regulatory submissions, and ensuring adherence to FDA/ICH guidelines. Strong leadership and communication are essential for success.