Senior Director, Corporate Finance & Strategy

Iren Group; Madrid; Remote; EUR 70,000 - 95,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role. Responsibilities include generating SDTM/ADaM specifications, datasets, and define.xml, plus overseeing CROs and supporting regulatory submissions.

Strong SAS, CDISC, and leadership skills are essential. Requirements include a Bachelor's in CS/Data Science/Math/Statistics and 7+ years in biotech/pharma biometrics, with proficiency in SAS and CDISC standards.

Qualifications

• Bachelor's degree in CS/data science/math/statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma.
• SAS expertise with CDISC standards (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions and FDA interactions.
• Strong communication and leadership; able to work independently.

Responsibilities

• Generate SDTM/ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results.
• Oversee CRO deliverables and ensure timelines.
• Support preparation of clinical study reports and regulatory submissions.

Skills

SAS programming

R

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Leadership

Data QC

Unix/Linux

Python

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

Python

Git

Shiny

Job description

Senior/Principal Statistical Programmer SAS + R (Remote)

Principal Statistical Programmer responsibilities include generating SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies; developing SAS programs to generate datasets, complex listings, tables and graphs; delivering high-quality statistical programming results; overseeing CRO's statistical programming deliverables; supporting preparation of clinical study reports, regulatory submissions and exploratory analyses; understanding FDA regulations affecting reporting of clinical trial data; contributing to the creation, maintenance and validation of standards for programming tools, outputs and macros; developing CRFs, edit check specifications, and data validation plans; providing review and/or author data transfer specifications for external vendor data; collaborating with internal and external functions to meet timelines; providing review and/or author SOPs and/or Work Instructions related to statistical programming practices.

Here at Cytel we want our employees to succeed and we enable this through consistent training, development and support. Requirements include a bachelor\'s degree in computer science, data science, mathematics, or statistics; 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics; SAS programming expertise; extensive CDISC standards experience (SDTM, ADaM, Define.xml); experience supporting regulatory submissions and interacting with FDA/global authorities; ability to work independently; strong communication and leadership skills.

Preferred qualifications include pharmacokinetic data and neuroscience experience; proficiency in languages/tools beyond SAS (R, Python, Java, Shiny, Markdown, Unix/Linux, git).