Senior Statistical Programmer - Pharma Data & Submissions

Cytel; South Africa; On-site; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer to work within a sponsor-dedicated, embedded role on a global pharma client program. You’ll independently manage programming activities, oversee CRO work, and ensure high-quality SDTM/ADaM outputs in line with regulatory expectations.

The role emphasizes autonomy, collaboration with biostatistics and programming teams, and delivering robust reporting for trials and regulatory submissions.

Qualifications

• Bachelor's degree in computer science, statistics, or related field.
• 7+ years of statistical programming experience in biotech/pharma.
• Expert SAS programming with CDISC SDTM/ADaM and Define.xml experience.
• Experience supporting regulatory submissions with FDA/regulatory authorities.
• Excellent communication and leadership 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 graphs.
• Deliver high-quality statistical programming results and validate SAS/R programs.
• Oversee CRO programmers to meet pre-specified timelines.
• Support preparation of CSRs, regulatory submissions and DSURs.
• Adhere to FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors and partners to meet timelines.
• Provide SOPs and Work Instructions for statistical programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Data management

FDA regulations

Leadership

Independent work

Communication

Education

Bachelor's degree in Computer Science/Statistics

Tools

SAS

R

Unix/Linux

Git

Job description

Cytel seeks a Principal Statistical Programmer to work within a sponsor-dedicated, embedded role on a global pharma client program. You’ll independently manage programming activities, oversee CRO work, and ensure high-quality SDTM/ADaM outputs in line with regulatory expectations.

The role emphasizes autonomy, collaboration with biostatistics and programming teams, and delivering robust reporting for trials and regulatory submissions.