Principal Statistical Programmer (SAS + R) – Remote

Capsicum Culinary Studio; Cape Town; Remote; ZAR 1,983,000 - 2,975,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to be remotely embedded with one of our pharmaceutical clients. You will lead data programming for SDTM/ADaM, create define.xml, and oversee CRO deliverables while ensuring regulatory compliance and high-quality outputs.

You will work with a diverse team, provide expert support, and contribute to CSRs, submissions, DSURs and exploratory analyses, operating with autonomy in a fully remote setting.

Qualifications

• 7+ years as Statistical Programmer in biotech/pharma clinical development.
• Exceptional SAS programming and CDISC standards expertise.
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently with strong communication and leadership.
• Proficiency in R, Python and other analytical tools.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs for clinical programs.
• Oversee CRO deliverables to meet timelines.
• Prepare CSRs, regulatory submissions, publications, and DSURs.
• Follow FDA regulations for electronic submissions.
• Create and validate standards for tools, outputs, and macros.
• Develop CRFs, edit checks, data validation plans.
• Provide data transfer specifications for external data.
• Collaborate with internal/external teams to hit milestones.
• Review and author SOPs and work instructions.

Skills

SAS programming

CDISC SDTM

CDISC ADaM

Define.xml

Regulatory submissions

FDA/ICH regulation

Communication skills

Leadership

R (proficiency)

Python (proficiency)

Unix/Linux

Git

Education

Bachelor's degree (CS/Data Science/Math/Statistics)

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to be remotely embedded with one of our pharmaceutical clients. You will lead data programming for SDTM/ADaM, create define.xml, and oversee CRO deliverables while ensuring regulatory compliance and high-quality outputs.

You will work with a diverse team, provide expert support, and contribute to CSRs, submissions, DSURs and exploratory analyses, operating with autonomy in a fully remote setting.