Principal Statistical Programmer - Remote (SAS + R)

Capital H Staffing And Advisory Solutions; Pietermaritzburg; Remote; ZAR 1,997,000 - 2,995,000; Full time

Job summary

Cytel Inc. invites applications for a Senior/Principal Statistical Programmer SAS + R (Remote). You will join as sponsor-dedicated, embedded with one pharmaceutical client, delivering high-quality programming and data analysis across SDTM/ADaM, defines.xml, and study reports.

You will lead programming work, oversee CROs, ensure regulatory compliance, and collaborate with statisticians and data managers. A Bachelor's in a quantitative field and 7+ years' experience are expected; strong SAS

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, FDA/ICH regulation.
• Experience supporting regulatory submissions and interaction with FDA/global authorities.
• Ability to work independently.
• Outstanding communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs tailored to clinical programs' needs.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external data.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulations

Data analysis

Leadership

Communication

Independent work

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. invites applications for a Senior/Principal Statistical Programmer SAS + R (Remote). You will join as sponsor-dedicated, embedded with one pharmaceutical client, delivering high-quality programming and data analysis across SDTM/ADaM, defines.xml, and study reports.

You will lead programming work, oversee CROs, ensure regulatory compliance, and collaborate with statisticians and data managers. A Bachelor's in a quantitative field and 7+ years' experience are expected; strong SAS