Senior Principal Statistical Programmer – Remote

Placements24; East London; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on sponsor-driven projects within the pharmaceutical industry. The role focuses on implementing reporting and analysis activities for sponsor trials, including SDTM/ADaM development and regulatory submissions.

The candidate will lead SAS and R programming efforts, oversee CRO deliverables, and ensure high-quality outputs in line with FDA/ICH guidelines. A senior, autonomous programmer with strong leadership is required.

Qualifications

• Bachelor's degree in CS, data science, math or statistics.
• 7+ years as a Statistical Programmer in biotech/pharma clinical development.
• Exceptional SAS programming skills for clinical reporting & analysis.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interactions with authorities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer s' guides and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.
• Comply with FDA/ICH regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in CRF development, edit checks, and data validation plans.
• Provide data transfer specs for external vendors.
• Collaborate with internal/external partners to meet project timelines.
• Draft SOPs and work instructions for statistical programming practices.

Skills

SDTM/ADaM concepts

SAS programming

R programming

CDISC standards

Team leadership

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on sponsor-driven projects within the pharmaceutical industry. The role focuses on implementing reporting and analysis activities for sponsor trials, including SDTM/ADaM development and regulatory submissions.

The candidate will lead SAS and R programming efforts, oversee CRO deliverables, and ensure high-quality outputs in line with FDA/ICH guidelines. A senior, autonomous programmer with strong leadership is required.