Principal Statistical Programmer – SAS/R, Remote, Pharma

Lucanetgroup; Santander; Remote; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to contribute to clinical development programs for a global sponsor. You will generate SDTM/ADaM outputs, develop SAS and R programs, and oversee CRO deliverables to ensure high-quality data and on-time completion.

Reporting to the Director of Biostatistics and Programming in the FSP Services unit, you will work independently with minimal supervision, support regulatory submissions, and perform exploratory analyses while

Qualifications

• Bachelor's degree in computer science, data science, mathematics.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs which generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs Tailored to clinical development programs' needs.
• Oversee CRO's statistical programming deliverables for multiple studies to ensure quality and timelines.
• Support the preparation of clinical study reports, regulatory submissions, publications, and exploratory analyses.
• Understand and follow FDA regulations affecting reporting of clinical trial data (GxP and eSubmissions).
• Contribute to development and validation of standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet project timelines and goals
• Provide review/author SOPs and Work Instructions related to statistical programming practices

Skills

SDTM/ADaM specs

CRO oversight

GxP compliance

Statistical programming

SAS & R

Education

Bachelor's degree in Computer Science/Data Science/Mathematics

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to contribute to clinical development programs for a global sponsor. You will generate SDTM/ADaM outputs, develop SAS and R programs, and oversee CRO deliverables to ensure high-quality data and on-time completion.

Reporting to the Director of Biostatistics and Programming in the FSP Services unit, you will work independently with minimal supervision, support regulatory submissions, and perform exploratory analyses while