Principal Statistical Programmer: Lead Clinical Data & Submissions

Cytel; United Kingdom; On-site; GBP 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to operate within a sponsor-driven program embedded with a leading pharmaceutical client. The role focuses on delivering high-quality statistical programming for clinical trials, with strong independence and leadership within a biometrics team.

You will oversee CRO contributions and ensure compliance with FDA/ICH guidelines. The ideal candidate will have extensive CDISC experience (SDTM/ADaM/Define.xml), expert SAS skills, and a track record of

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and experience implementing statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS/R programs tailored to clinical development needs and validate them.
• Oversee CRO statistical programming deliverables to meet timelines across studies.
• Contribute to the preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Skills

7+ years experience

Independent work

Leadership

Communication skills

Education

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

Tools

SAS

R

Python

Define.xml tools

Job description

Cytel is seeking a Principal Statistical Programmer to operate within a sponsor-driven program embedded with a leading pharmaceutical client. The role focuses on delivering high-quality statistical programming for clinical trials, with strong independence and leadership within a biometrics team.

You will oversee CRO contributions and ensure compliance with FDA/ICH guidelines. The ideal candidate will have extensive CDISC experience (SDTM/ADaM/Define.xml), expert SAS skills, and a track record of