Senior Statistical Programmer — Remote Lead for Trials Data

Placements24; East London; A distancia; ZAR 1.997.000 - 2.995.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) embedded with a pharmaceutical client, delivering high-quality SAS and R programming for clinical trials. You will lead data standards, create datasets, tables, and graphs, and oversee CRO programmers to ensure on-time delivery.

The role requires a minimum 7 years in biotech/pharma programming, strong CDISC expertise, and experience with regulatory submissions. Excellent communication and leadership are essential.

Formación

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma.
• Expert SAS programming for clinical development and CDISC (SDTM/ADaM/Define.xml).
• Experience with regulatory submissions to FDA/global authorities.
• Ability to work independently and lead initiatives.
• Strong written and verbal communication and leadership.

Responsabilidades

• Generate SDTM/ADaM specifications, datasets, reviewer's guides, and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs for clinical development programs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of clinical study reports and regulatory submissions.
• Follow FDA/ICH regulations for electronic submissions and coding standards.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs, vendors, and partners to meet timelines.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication

Independent work

Biostatistics knowledge

Educación

Bachelor's degree in computer science/data science/statistics

Herramientas

SAS

R

Python

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) embedded with a pharmaceutical client, delivering high-quality SAS and R programming for clinical trials. You will lead data standards, create datasets, tables, and graphs, and oversee CRO programmers to ensure on-time delivery.

The role requires a minimum 7 years in biotech/pharma programming, strong CDISC expertise, and experience with regulatory submissions. Excellent communication and leadership are essential.