Senior Principal Statistical Programmer — Remote

Placements24; East London; Remote; ZAR 900,000 - 1,400,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R for remote engagement with one global pharma client.

You will lead programming activities in a Sponsor-dedicated environment, delivering SDTM/ADaM specs, datasets, and reports with autonomy. The role requires 7+ years in statistical programming, expertise in SAS, SDTM/ADaM, Define.xml, and FDA/ICH guidelines, with experience overseeing CROs and supporting regulatory submissions.

Qualifications

• Bachelor's degree in CS/DS/Math/Statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Biometric team.
• Expert SAS programming in clinical development.
• CDISC SDTM/ADaM/Define.xml, FDA/ICH regulation.
• Regulatory submissions experience.
• Ability to work independently; strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, Define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, graphs.
• Deliver high-quality results with SAS and/or R; support CROs.
• Oversee CRO's programming deliverables to meet timelines.
• Support study reports, regulatory submissions, publications, DSUR.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for tools, outputs, macros.
• Develop CRFs, edit checks, data validation plans.
• Provide data transfer specifications to external vendors.
• Collaborate with internal/external partners to meet timelines.
• Review and/or author SOPs and work instructions.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulation

Leadership

Regulatory submissions

Independent work

Education

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R for remote engagement with one global pharma client.

You will lead programming activities in a Sponsor-dedicated environment, delivering SDTM/ADaM specs, datasets, and reports with autonomy. The role requires 7+ years in statistical programming, expertise in SAS, SDTM/ADaM, Define.xml, and FDA/ICH guidelines, with experience overseeing CROs and supporting regulatory submissions.