Lead Statistical Programmer (SAS & R) — Remote

Nelson Mandela University; South Africa; Remote; ZAR 900,000 - 1,200,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client. You will independently implement data reporting and analysis activities, develop SDTM/ADaM outputs, and oversee CRO programming to ensure high-quality deliverables.

The role requires 7+ years in statistical programming, strong SAS skills, CDISC expertise, and experience with regulatory submissions. A remote, international setup with Cytel support is offered.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Biometric team or similar.
• Exceptional SAS programming skills for clinical development.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• 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 guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external data.
• Collaborate with CROs, vendors, and partners to meet timelines.
• Assist in writing SOPs and work instructions for programming practices.

Skills

SAS programming

Statistical programming

CDISC standards

Regulatory submissions

Leadership

Communication

R programming

Unix/Linux

Education

Bachelor's degree in computer science / data science / mathematics / statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a pharmaceutical client. You will independently implement data reporting and analysis activities, develop SDTM/ADaM outputs, and oversee CRO programming to ensure high-quality deliverables.

The role requires 7+ years in statistical programming, strong SAS skills, CDISC expertise, and experience with regulatory submissions. A remote, international setup with Cytel support is offered.