Senior Principal Statistical Programmer — SAS/R, Remote

The Talent Room; Badalona; Remote; EUR 60,000 - 90,000; Full time

Job summary

The Talent Room is seeking a Senior/Principal Statistical Programmer (SAS + R) to join as a sponsor-dedicated professional, fully embedded with a pharmaceutical client. Remote working arrangement offered, with autonomy to lead programming deliverables.

You will implement reporting and analysis activities across trials, oversee CROs, and contribute to study reports and regulatory submissions, applying GCP and FDA guidelines.

Qualifications

• Extensive experience in statistical programming for clinical trials.
• Strong knowledge of SDTM and ADaM data structures.
• Experience supervising CRO programmers and delivering compliant reports.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review

Skills

SAS programming

R programming

Clinical trial statistics

Tools

SAS

R

Job description

The Talent Room is seeking a Senior/Principal Statistical Programmer (SAS + R) to join as a sponsor-dedicated professional, fully embedded with a pharmaceutical client. Remote working arrangement offered, with autonomy to lead programming deliverables.

You will implement reporting and analysis activities across trials, oversee CROs, and contribute to study reports and regulatory submissions, applying GCP and FDA guidelines.