Senior Principal Statistical Programmer (SAS + R) - Remote

Agileengine, Llc.; Alicante; Hybrid; EUR 80,000 - 116,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer for a fully remote position, embedded with a pharmaceutical client. You will lead programming activities across SDTM/ADaM, develop SAS and R code, and supervise CRO work to ensure timely, high-quality data outputs for submissions.

You will implement standards, support study reports and regulatory submissions, and ensure compliance with FDA/GCP guidelines. This is a senior role with considerable autonomy and ownership.

Qualifications

• Experienced in clinical development programming.
• Proven ability to generate SDTM/ADaM datasets and specs.
• Knowledge of regulatory standards for submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, listings, tables and graphs
• Deliver high-quality SAS and/or R programs tailored to clinical programs' needs
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of study reports, submissions and DSURs
• Follow FDA regulations and GCP for electronic submissions
• Create, maintain, document, and validate standards for tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review/author data transfer specs for external vendor data
• Collaborate with internal/external partners to meet timelines
• Review/author SOPs and work-related documents

Skills

SAS programming

R programming

Clinical data analysis

SDTM/ADaM specifications

CRO oversight

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer for a fully remote position, embedded with a pharmaceutical client. You will lead programming activities across SDTM/ADaM, develop SAS and R code, and supervise CRO work to ensure timely, high-quality data outputs for submissions.

You will implement standards, support study reports and regulatory submissions, and ensure compliance with FDA/GCP guidelines. This is a senior role with considerable autonomy and ownership.