Principal Statistical Programmer (SAS/R) — Remote

Placements24; Mbombela (Nelspruit); Remote; ZAR 900,000 - 1,200,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, dedicated to a sponsor client within the pharma/biotech space.

You will develop SDTM/ADaM documents, write SAS programs, and oversee CRO deliverables across multiple studies while ensuring regulatory compliance. The role requires 7+ years of programming experience in clinical development, proficiency in SAS and CDISC standards, and strong communication and leadership abilities.

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
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation
• Experience supporting regulatory submissions and interaction with regulatory authorities
• Must be able to work independently and demonstrate strong leadership and communication skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables and complex graphs
• Deliver high-quality SAS/R programming results and validate underlying code
• Oversee CROs' programming deliverables to meet timelines and quality
• Support preparation of clinical study reports, regulatory submissions and DSURs
• Adhere to FDA regulations and GCP for electronic submissions
• Develop and validate standards for programming tools, outputs and macros
• Collaborate with CROs, vendors and internal teams to meet project goals
• Create data transfer specifications for external vendor data
• Develop CRFs, edit checks and data validation plans
• Prepare SOPs and Work Instructions related to statistical programming practices

Skills

SAS programming

Leadership

Communication

Independent work

Regulatory familiarity

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, dedicated to a sponsor client within the pharma/biotech space.

You will develop SDTM/ADaM documents, write SAS programs, and oversee CRO deliverables across multiple studies while ensuring regulatory compliance. The role requires 7+ years of programming experience in clinical development, proficiency in SAS and CDISC standards, and strong communication and leadership abilities.