Principal Statistical Programmer (SAS + R) – Remote

Empresa De Gestión Y Selección; Guadalajara; Remote; EUR 90,000 - 130,000; Full time

Job summary

Empresa De Gestión Y Selección is seeking a Senior/Principal Statistical Programmer for a fully remote role with a sponsor-dedicated setup. The position emphasizes independent work on clinical programs, oversight of CROs, and delivery of SDTM/ADaM artifacts for regulatory submissions.

The ideal candidate has extensive SAS and R experience in clinical development, with strong ownership and problem-solving skills to support trials and reports while adhering to FDA and GCP guidelines.

Qualifications

• Senior Statistical Programmer with extensive SAS and R experience.
• Experience in clinical development programs and regulatory submissions.
• Ability to review and oversee CRO deliverables and data transfers.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, and define.xml files.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming outputs for trials.
• Oversee CRO programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for tools, outputs, and macros.
• Assist in CRF development, edit checks, and data validation plans.
• Coordinate with CROs and vendors to meet goals.
• Review SOPs and work instructions related to statistics.

Skills

SAS

R

Statistical programming

Clinical development

CRO oversight

Job description

Empresa De Gestión Y Selección is seeking a Senior/Principal Statistical Programmer for a fully remote role with a sponsor-dedicated setup. The position emphasizes independent work on clinical programs, oversight of CROs, and delivery of SDTM/ADaM artifacts for regulatory submissions.

The ideal candidate has extensive SAS and R experience in clinical development, with strong ownership and problem-solving skills to support trials and reports while adhering to FDA and GCP guidelines.