Senior Principal Statistical Programmer - Remote

Sasso Consulting; Johannesburg; À distance; ZAR 1 990 000 - 2 985 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on a global pharmaceutical client. The role involves leading programming activities, overseeing CRO deliverables, and ensuring high-quality data analyses for regulatory submissions.

Strong CDISC experience and FDA/ICH familiarity are essential. The successful candidate will work independently with minimal supervision, contribute to study reports and DSURs, and collaborate with cross-functional teams to

Qualifications

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

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, graphs with descriptive and inferential stats.
• Deliver high-quality SAS/R outputs and validate programs for clinical development programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Comply with FDA regulations and electronic submission guidelines.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in CRF development, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals.
• Draft SOPs/Work Instructions for statistical programming practices.

Connaissances

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent worker

Strong communication

Leadership

Formation

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

Outils

R

Python

Java

Shiny

Unix/Linux

Git

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on a global pharmaceutical client. The role involves leading programming activities, overseeing CRO deliverables, and ensuring high-quality data analyses for regulatory submissions.

Strong CDISC experience and FDA/ICH familiarity are essential. The successful candidate will work independently with minimal supervision, contribute to study reports and DSURs, and collaborate with cross-functional teams to