Senior Statistical Programmer (SAS + R) — Remote

Farmatalent; Valencia; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated program, embedded with a pharmaceutical client.

You will independently manage programming deliverables across SDTM/ADaM, develop complex SAS and R code, and oversee CRO workstreams to ensure timely, high-quality data outputs for regulatory submissions. Ideal candidates have a strong background in CDISC standards, experience with FDA/ICH guidelines, and the ability to lead technical teams while

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM/Define.xml experience.
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently.
• Strong communication and leadership skills.

Responsibilities

• 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 SAS and/or R programs tailored to clinical development needs.
• Oversee CROs' statistical programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR.
• Follow FDA regulations and Good Clinical Practice for electronic submissions.
• Contribute to creation and validation of standards for programming tools and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal/external functions to meet project goals and timelines.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Biostatistics collaboration

Education

Bachelor's degree in CS/Data Science/Statistics

Tools

SAS

R

CDISC tooling

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated program, embedded with a pharmaceutical client.

You will independently manage programming deliverables across SDTM/ADaM, develop complex SAS and R code, and oversee CRO workstreams to ensure timely, high-quality data outputs for regulatory submissions. Ideal candidates have a strong background in CDISC standards, experience with FDA/ICH guidelines, and the ability to lead technical teams while