Senior Statistical Programmer - SAS, SDTM/ADaM (Remote)

e-Merge IT Recruitment; Johannesburg; Remote; ZAR 1,570,000 - 2,644,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. The role involves independent programming, SDTM/ADaM development, and oversight of CRO deliverables with support from Cytel.

Applicants should have extensive SAS experience, CDISC standards, and regulatory submissions exposure. Responsibilities include creating datasets, complex listings and tables, and contributing to study reports, DSURs, and regulatory submissions,

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in biotech/pharma clinical development biometrics.
• Exceptional SAS programming skills and clinical programming processes.
• Extensive CDISC standards experience (SDTM/ADaM/Define.xml) and regulations.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical programs and analyses.
• Oversee CRO programming deliverables for multiple studies and timelines.
• Support clinical study reports, regulatory submissions, publications and DSURs.
• Comply with FDA/ICH regulations and eSubmissions guidelines.
• Create and validate standards for programming tools, outputs and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with CROs, vendors and partners to meet project goals.
• Review SOPs and work instructions related to statistical programming.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

R programming

Regulatory submissions

Independent worker

Leadership

Communication skills

Python

Unix/Linux

Git

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. The role involves independent programming, SDTM/ADaM development, and oversight of CRO deliverables with support from Cytel.

Applicants should have extensive SAS experience, CDISC standards, and regulatory submissions exposure. Responsibilities include creating datasets, complex listings and tables, and contributing to study reports, DSURs, and regulatory submissions,