Principal Statistical Programmer (Remote) SAS + R

Tamarind Intelligence Group; La Coruña; Remote; EUR 70,000 - 95,000; Full time

Job summary

Cytel invites a Senior/Principal Statistical Programmer to join a sponsor-dedicated remote role, embedded with a leading pharmaceutical client. You will lead programming efforts across SDTM/ADaM, develop SAS and R solutions, and guide CRO programmers to ensure high-quality data deliverables.

Based in Spain, you will contribute to regulatory submissions, study reports, and exploratory analyses while adhering to FDA guidelines and good clinical practice.

Qualifications

• Senior statistical programmer with extensive experience in clinical development programs.
• Experience overseeing CRO programming deliverables and meeting pre-specified timelines.
• Knowledge of FDA regulations and guidelines for regulatory submissions.

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

R

SDTM

ADaM

Clinical programming

Job description

Cytel invites a Senior/Principal Statistical Programmer to join a sponsor-dedicated remote role, embedded with a leading pharmaceutical client. You will lead programming efforts across SDTM/ADaM, develop SAS and R solutions, and guide CRO programmers to ensure high-quality data deliverables.

Based in Spain, you will contribute to regulatory submissions, study reports, and exploratory analyses while adhering to FDA guidelines and good clinical practice.