Senior Statistical Programmer for Clinical Trials & SAS

Cytel; España; Presencial; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Principal Statistical Programmer to work embedded with one of our pharmaceutical clients, with Cytel backing the program.

You will lead SAS programming, develop SDTM/ADaM specs, oversee CRO deliverables, and support regulatory submissions. Strong independence, leadership, and knowledge of FDA/ICH regulations are required.

This sponsor-dedicated role offers exposure to multiple studies and collaboration with cross-functional teams in a fast-paced biostatistics environment.

Formación

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Experience in oncology endpoints and analyses.
• Exceptional SAS programming skills and CDISC SDTM/ADaM/Define.xml expertise.
• Experience supporting regulatory submissions and FDA/ICH regulation.
• Must be able to work independently.
• Outstanding written and verbal communication and leadership.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs which generate datasets, listings, tables, and graphs.
• Deliver high-quality programming results including developing, validating, and maintaining SAS/R programs.
• Oversee CROs’ statistical programming deliverables to meet timelines.
• Support the preparation of CSR, regulatory submissions, publications, DSUR, and analyses.
• Understand and follow FDA/ICH regulations for reporting clinical trial data.
• Contribute to the creation and validation of standards for programming tools and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review and/or author data transfer specifications for external vendor data.
• Collaborate with internal and external functions to meet project goals.
• Contribute to SOPs and Work Instructions related to statistical programming practices.

Conocimientos

SAS programming

Leadership

Communication skills

Independent work

FDA/ICH regulation understanding

R

Python

Unix/Linux

Git

Java

Educación

Bachelor’s degree in computer science, data science, mathematics, or statistics

Herramientas

CDISC SDTM

CDISC ADaM

Define.xml

SAS

R

Python

Unix/Linux

Git

Descripción del empleo

Cytel is seeking a Principal Statistical Programmer to work embedded with one of our pharmaceutical clients, with Cytel backing the program.

You will lead SAS programming, develop SDTM/ADaM specs, oversee CRO deliverables, and support regulatory submissions. Strong independence, leadership, and knowledge of FDA/ICH regulations are required.

This sponsor-dedicated role offers exposure to multiple studies and collaboration with cross-functional teams in a fast-paced biostatistics environment.