Principal Statistical Programmer: SAS + R (Remote)

Deel; Vitoria; À distance; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Cytel seeks a Senior/Principal Statistical Programmer to work remotely with a pharmaceutical client network. You'll lead SAS and R programming for SDTM/ADaM, oversee CRO deliverables, and ensure regulatory-quality outputs.

A strong background in CDISC standards and FDA interactions is essential. Ideal candidates have 7+ years in biotech/pharma biometrics, independent working style, excellent communication, and leadership skills.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
• Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment.
• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities.
• Must be able to work independently and have outstanding communication and leadership skills.

Responsabilités

• 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 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.
• 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 and/or author data transfer specifications for external vendor data.
• Collaborate with internal and external functions to ensure meeting project timelines and goals.
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.

Connaissances

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Formation

Bachelor's degree (CS/Statistics/Math)

Outils

R programming

Python

Shiny

Unix/Linux

Git

Java

Description du poste

Cytel seeks a Senior/Principal Statistical Programmer to work remotely with a pharmaceutical client network. You'll lead SAS and R programming for SDTM/ADaM, oversee CRO deliverables, and ensure regulatory-quality outputs.

A strong background in CDISC standards and FDA interactions is essential. Ideal candidates have 7+ years in biotech/pharma biometrics, independent working style, excellent communication, and leadership skills.