Lead Statistical Programmer - SAS & R (Remote)

Alcampo; Zaragoza; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a pharmaceutical client program. You will lead programming activities, implement SDTM/ADaM specifications, and deliver high-quality datasets, listings, tables and figures for regulatory submissions.

The role requires strong SAS and R expertise, experience overseeing CRO programmers, and adherence to FDA/GCP guidelines in a global development context.

Qualifications

• Senior statistical programmer with clinical trial experience.
• Proficiency in SAS programming for complex datasets and analyses.
• Experience with SDTM/ADaM specifications and regulatory outputs.
• Ability to coordinate CRO programmers and ensure timely deliverables.
• Knowledge of FDA regulations and good clinical practice (GCP).

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results including SAS and/or R programs.
• Oversee CRO's programming deliverables to ensure quality and timelines.
• Assist in preparation of clinical study reports and regulatory submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in development of CRFs and data validation plans.
• Provide technical review and guidance where needed.

Skills

SAS

R

SDTM/ADaM

GCP

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a pharmaceutical client program. You will lead programming activities, implement SDTM/ADaM specifications, and deliver high-quality datasets, listings, tables and figures for regulatory submissions.

The role requires strong SAS and R expertise, experience overseeing CRO programmers, and adherence to FDA/GCP guidelines in a global development context.