Remote Principal Statistical Programmer (SAS/R)

Placements24; South Africa; Remote; ZAR 700,000 - 1,100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to drive SDTM/ADaM data delivery across multiple studies. You will develop SAS/R programs, supervise CROs, and contribute to regulatory submissions under FDA guidelines.

The role requires 7+ years in biotech/pharma programming, strong CDISC knowledge, and the ability to work independently with leadership and communication skills.

Qualifications

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma
• Expert SAS programming for clinical development and CDISC SDTM/ADaM
• Experience supporting regulatory submissions and FDA interactions
• Ability to work independently and lead CRO programming deliverables

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs
• Oversee CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses
• Understand and follow FDA regulations for reporting clinical trial data
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Collaborate with internal and external functions to meet project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Skills

SAS programming

Statistical programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

R programming

Education

Bachelor's degree in CS/Math/Stats

Tools

R

Python

Java

Shiny

Git

Unix/Linux

Markdown

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to drive SDTM/ADaM data delivery across multiple studies. You will develop SAS/R programs, supervise CROs, and contribute to regulatory submissions under FDA guidelines.

The role requires 7+ years in biotech/pharma programming, strong CDISC knowledge, and the ability to work independently with leadership and communication skills.