Principal Statistical Programmer (Remote) - SAS & R Lead

Placements24; Pietermaritzburg; A distancia; ZAR 1.492.000 - 1.990.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead statistical programming activities for a global pharmaceutical client.

You will generate SDTM/ADaM datasets, define.xml, and complex listings, graphs, and tables, using SAS and R, with oversight of CRO programmers and collaboration with biostatistics teams. The role requires 7+ years of experience in clinical development, strong CDISC knowledge, and experience with regulatory submissions and FDA/ICH guidelines.

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer on Biotech/Pharma Biometric team.
• Exceptional SAS programming skills in clinical development.
• CDISC SDTM/ADaM and Define.xml experience.
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently and lead CRO programming teams.
• Strong written and verbal communication and leadership.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, define.xml and reviewer’s guides.
• Develop SAS and R programs for datasets, listings, tables, and graphs.
• Oversee CRO programming deliverables across studies.
• Support clinical study reports and regulatory submissions.
• Ensure compliance with FDA/ICH and GCP guidelines.
• Develop and maintain programming standards and macros.
• Contribute to CRFs and data validation plans.
• Collaborate with internal/external partners to meet timelines.
• Create SOPs and work instructions for statistics programming.

Conocimientos

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

FDA/ICH rules

Leadership

Communication

Independent work

CRO oversight

Educación

Bachelor's degree in CS/DS/Math/Stats

Herramientas

Python

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead statistical programming activities for a global pharmaceutical client.

You will generate SDTM/ADaM datasets, define.xml, and complex listings, graphs, and tables, using SAS and R, with oversight of CRO programmers and collaboration with biostatistics teams. The role requires 7+ years of experience in clinical development, strong CDISC knowledge, and experience with regulatory submissions and FDA/ICH guidelines.