Principal Statistical Programmer (Remote)

Ethos; La Coruña; Remote; EUR 90,000 - 130,000; Full time

Job summary

Ethos is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role embedded with a pharmaceutical client. You will lead programming efforts across SDTM/ADaM, develop complex datasets, and generate tables, listings and figures for clinical studies.

You will supervise CRO programmers, ensure high-quality outputs, and contribute to regulatory submissions and study reports while adhering to FDA guidelines and GxP practices.

Qualifications

• Experience with SAS and R in clinical development.
• Knowledge of SDTM/ADaM data structures and datasets.
• Ability to generate complex tables, listings and figures.
• Understanding of FDA/ICH regulatory requirements for reporting.

Responsibilities

• Generate SDTM and ADaM specs, datasets, reviewer’s guides, define.xml.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for trials and submissions.
• Oversee CRO programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions and DSURs.
• Follow FDA regulations and GxP for electronic submissions.
• Contribute to standards for programming tools and macros.
• Collaborate with CROs and vendors to hit project goals.
• Provide data transfer specifications for external data.

Skills

SAS

R

Clinical programming

SDTM

ADaM

Regulatory standards

Quality Assurance

Tools

CDISC standards

define.xml

GxP

Job description

Ethos is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role embedded with a pharmaceutical client. You will lead programming efforts across SDTM/ADaM, develop complex datasets, and generate tables, listings and figures for clinical studies.

You will supervise CRO programmers, ensure high-quality outputs, and contribute to regulatory submissions and study reports while adhering to FDA guidelines and GxP practices.