Principal Statistical Programmer (SAS/R) - Remote, Lead & Deliver

Accès Personnel; South Africa; À distance; ZAR 1 997 000 - 2 995 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with a sponsor-dedicated client in pharma. You will lead programming activities, oversee CRO deliverables, and ensure high-quality SDTM/ADaM outputs across studies.

Requirements include 7+ years in clinical programming, CDISC standards expertise, regulatory submissions experience, and strong communication and leadership. Proficiency in SAS and R, plus Python/Java is preferred, with remote work flexibility.

Qualifications

• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• Extensive CDISC standards expertise (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently with minimal supervision
• Strong written and verbal communication and leadership skills

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs that produce datasets, listings, tables and graphs
• Deliver high-quality SAS and/or R programming outputs for clinical development programs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Review data transfer specifications for external vendor data
• Collaborate with CROs, vendors, and partners to meet project goals
• Draft SOPs/Work Instructions related to statistical programming practices

Connaissances

Excellent communication

Leadership

Independent worker

Formation

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

Outils

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

git

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with a sponsor-dedicated client in pharma. You will lead programming activities, oversee CRO deliverables, and ensure high-quality SDTM/ADaM outputs across studies.

Requirements include 7+ years in clinical programming, CDISC standards expertise, regulatory submissions experience, and strong communication and leadership. Proficiency in SAS and R, plus Python/Java is preferred, with remote work flexibility.