Principal Statistical Programmer (SAS/R) - Remote Lead

Hoteljobs; South Africa; Remote; ZAR 1,658,000 - 2,487,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated role for a global pharmaceutical client. The role involves independent programming, overseeing CROs, and delivering SDTM/ADaM datasets and define.xml files for multiple trials.

Applicants should have 7+ years in statistical programming, strong SAS/R skills, CDISC experience, and familiarity with regulatory submissions. Excellent communication and leadership abilities are required.

Qualifications

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

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs tailored to clinical programs.
• Oversee CROs’ statistical programming deliverables to meet timelines.
• Support preparation of study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Clinical trial data analysis

Regulatory submissions experience

Independent working

Leadership

Data management

Education

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

Tools

SAS

R

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated role for a global pharmaceutical client. The role involves independent programming, overseeing CROs, and delivering SDTM/ADaM datasets and define.xml files for multiple trials.

Applicants should have 7+ years in statistical programming, strong SAS/R skills, CDISC experience, and familiarity with regulatory submissions. Excellent communication and leadership abilities are required.