Senior Principal Statistical Programmer (SAS + R) - Remote

Estel Ingeniería Y Obras S.A.; Islas Baleares; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one of our pharmaceutical clients. You will be responsible for delivering high-quality programming for clinical development programs and independent work with minimal supervision.

Responsibilities include generating SDTM and ADaM specifications, datasets, tables, listings, and graphs, supporting regulatory submissions, and overseeing CRO programming to ensure timely, compliant results across therapeutic

Qualifications

• Senior statistical programmer with extensive clinical trial experience.
• Proficient in generating SDTM/ADaM datasets, listings, and define.xml.
• Ability to supervise CRO programmers and ensure high-quality outputs.

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, and 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, DSURs, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data including GCP
• 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

CDISC SDTM/ADaM

GCP/FDA guidelines

CRO oversight

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one of our pharmaceutical clients. You will be responsible for delivering high-quality programming for clinical development programs and independent work with minimal supervision.

Responsibilities include generating SDTM and ADaM specifications, datasets, tables, listings, and graphs, supporting regulatory submissions, and overseeing CRO programming to ensure timely, compliant results across therapeutic