Remote Senior Principal Statistical Programmer (SAS & R)

Placements24; South Africa; Remote; ZAR 1,985,000 - 3,144,000; Full time

Job summary

Cytel Inc. invites a Senior/Principal Statistical Programmer (SAS + R) to join an embedded sponsor project on a remote basis. The role requires leading CRO programming efforts, delivering SDTM/ADaM outputs, and ensuring high-quality analyses for regulatory submissions.

You will work under the Director of Biostatistics, mentor junior team members, and implement CDISC standards across studies. The ideal candidate has 7+ years of pharma programming experience, strong SAS/R skills, and a track

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions and interactions with FDA/ICH.
• Ability to work independently and lead teams.
• Strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specs, datasets, define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs.
• Oversee CROs' programming deliverables to meet timelines.
• Support regulatory submissions, study reports, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and internal partners.
• Review SOPs and work instructions related to programming.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

FDA/ICH regulations

Leadership & communication

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. invites a Senior/Principal Statistical Programmer (SAS + R) to join an embedded sponsor project on a remote basis. The role requires leading CRO programming efforts, delivering SDTM/ADaM outputs, and ensuring high-quality analyses for regulatory submissions.

You will work under the Director of Biostatistics, mentor junior team members, and implement CDISC standards across studies. The ideal candidate has 7+ years of pharma programming experience, strong SAS/R skills, and a track