Principal Statistical Programmer (Remote, SAS/R)

Placements24; Gauteng; Remote; ZAR 1,492,000 - 2,985,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on pharmaceutical development programs.

You will design SDTM/ADaM data structures, write SAS and R code, and supervise CRO programmers to ensure timely, high-quality outputs while adhering to FDA/ICH regulations. Ideal candidates have 7+ years in Biotech/Pharma biometrics, strong leadership, and experience with regulatory submissions and Define.xml.

Qualifications

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills and experience in clinical development environments
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interactions with FDA or global authorities
• Ability to work independently and lead projects with strong communication and leadership skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies
• Develop SAS programs to create datasets, listings, tables and complex graphs
• Deliver high-quality programming results and validate SAS and/or R programs for clinical programs
• Oversee CROs' 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

Skills

Leadership

Independent work

Regulatory knowledge

Education

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

Tools

SAS

R

CDISC SDTM/ADaM

Define.xml

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on pharmaceutical development programs.

You will design SDTM/ADaM data structures, write SAS and R code, and supervise CRO programmers to ensure timely, high-quality outputs while adhering to FDA/ICH regulations. Ideal candidates have 7+ years in Biotech/Pharma biometrics, strong leadership, and experience with regulatory submissions and Define.xml.