Senior Principal Statistical Programmer - Remote

Hims & Hers; Murcia; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven clinical development projects. You will lead programming efforts in SAS and R, generate SDTM/ADaM datasets, and ensure high-quality outputs for regulated submissions.

In this role, you will oversee CRO programmers, contribute to study reports and regulatory submissions, and maintain standards for programming tools and documentation. Strong independence and leadership are essential.

Qualifications

• 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 Team or similar.
• Exceptional SAS programming skills and expertise in clinical development.
• Extensive experience with CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global authorities.
• Ability to work independently and deliver high-quality results.
• Strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R programs tailored to clinical development needs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Follow FDA regulations and guidelines for electronic submissions.
• Create, maintain, and validate standards for programming tools and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and internal teams to meet goals.
• Provide SOPs and Work Instructions for statistical programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Leadership

Regulatory submissions

Independent worker

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven clinical development projects. You will lead programming efforts in SAS and R, generate SDTM/ADaM datasets, and ensure high-quality outputs for regulated submissions.

In this role, you will oversee CRO programmers, contribute to study reports and regulatory submissions, and maintain standards for programming tools and documentation. Strong independence and leadership are essential.