Principal Statistical Programmer - SAS + R (Remote)

Bright Placements; Modimolle; Remote; ZAR 1,997,000 - 2,995,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely, embedded with a pharmaceutical client. You will drive SDTM/ADaM efforts, define.xml, listings, and complex graphs, collaborating with CROs to ensure high-quality outputs for regulatory submissions.

The role requires 7+ years in biostatistics programming, expert SAS skills, CDISC standards, and experience with regulatory submissions. Strong communication and leadership are essential for project success.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and development of statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Ability to work independently.
• Strong 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 complex graphs.
• Deliver high-quality programming results with SAS and/or R.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely, embedded with a pharmaceutical client. You will drive SDTM/ADaM efforts, define.xml, listings, and complex graphs, collaborating with CROs to ensure high-quality outputs for regulatory submissions.

The role requires 7+ years in biostatistics programming, expert SAS skills, CDISC standards, and experience with regulatory submissions. Strong communication and leadership are essential for project success.