Senior Principal Statistical Programmer - Remote (SAS + R)

Placements24; East London; Remote; ZAR 2.321.000 - 3.316.000; Vollzeit

Zusammenfassung

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a global pharmaceutical client. You will lead SDTM/ADaM development, generate datasets, listings, tables and graphs, and ensure regulatory-ready outputs while overseeing CRO partners.

You will contribute to study reports and submissions, adhere to FDA/GCP guidelines, and mentor junior programmers in a fast-paced, high-quality environment.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills for clinical development.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/ICH authorities.
• Ability to work independently and with leadership.
• Excellent written and verbal communication skills.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, review's guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS and/or R programs for clinical programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of CSRs, regulatory submissions and DSUR analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and macros.
• Assist in data validation plans and CRF/edit checks development.
• Coordinate with CROs, vendors and partners to meet project goals.
• Review and author SOPs and work instructions for statistical programming.

Kenntnisse

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication skills

Ausbildung

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

Tools

SAS

R

Python

Unix/Linux

Git

Jobbeschreibung

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a global pharmaceutical client. You will lead SDTM/ADaM development, generate datasets, listings, tables and graphs, and ensure regulatory-ready outputs while overseeing CRO partners.

You will contribute to study reports and submissions, adhere to FDA/GCP guidelines, and mentor junior programmers in a fast-paced, high-quality environment.