Senior Statistical Programmer (Remote) – SAS/R Expert

GAP Talent (Pty) Ltd; Cape Town; Remote; ZAR 1,990,000 - 3,150,000; Full time

Benefits offered by this job

Remote work

Career development

Health benefits

Paid time off

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer for a remote role, embedded with a pharmaceutical client, backed by Cytel. The candidate will independently lead programming activities across SDTM/ADaM, Define.xml, and regulatory submissions, while coordinating CRO work to ensure high-quality data outputs.

The role requires extensive SAS skills, CDISC expertise, FDA/ICH knowledge, and strong communication and leadership capabilities, with autonomy in a dynamic clinical development

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 in clinical development.
• Extensive experience with CDISC SDTM/ADaM/Define.xml, medical terminology, FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

R programming

Regulatory submissions

Leadership

Education

Bachelor’s degree in CS/Math/Statistics

Tools

SAS

R

Python

Job description

Cytel is seeking a Senior/Principal Statistical Programmer for a remote role, embedded with a pharmaceutical client, backed by Cytel. The candidate will independently lead programming activities across SDTM/ADaM, Define.xml, and regulatory submissions, while coordinating CRO work to ensure high-quality data outputs.

The role requires extensive SAS skills, CDISC expertise, FDA/ICH knowledge, and strong communication and leadership capabilities, with autonomy in a dynamic clinical development