Principal Statistical Programmer - Remote (SAS/R)

Standard Bank Group; Polokwane; Remote; ZAR 1,994,000 - 2,991,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer with expert SAS and R skills to work remotely on global biotech/pharma clinical development programs. You will lead programming efforts, oversee CRO deliverables, and ensure regulatory standards are met across multiple studies.

The role requires 7+ years of experience, CDISC expertise, and ability to operate independently in a Sponsor-dedicated setting with FDA/ICH familiarity.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Teams or similar.
• Exceptional SAS programming skills and experience in clinical development environments.
• Extensive CDISC SDTM/ADaM/Define.xml experience and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently with strong communication and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs tailored to clinical development needs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Follow FDA regulations and ICH guidelines for electronic submissions.
• Contribute to standards for programming tools and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review data transfer specifications for external vendors.

Skills

SAS programming

CDISC SDTM

CDISC ADaM

Define.xml

Regulatory submissions

Independent work

Communication skills

Leadership

R programming

Pharma clinical development

Education

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

Tools

SAS

R

Python

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer with expert SAS and R skills to work remotely on global biotech/pharma clinical development programs. You will lead programming efforts, oversee CRO deliverables, and ensure regulatory standards are met across multiple studies.

The role requires 7+ years of experience, CDISC expertise, and ability to operate independently in a Sponsor-dedicated setting with FDA/ICH familiarity.