Principal Statistical Programmer – Remote (SAS/R)

BVPD; South Africa; Remote; ZAR 900.000 - 1.400.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a global pharmaceutical client. You will lead SAS programming across SDTM/ADaM deliverables, develop complex listings and figures, and oversee CRO programming to ensure high quality, on-time outputs in a remote, sponsor-dedicated setting.

The role requires extensive CDISC experience, regulator-facing submission work, and strong communication and leadership abilities.

Qualifikationen

• Bachelor's degree in CS, data science, mathematics, or statistics.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team.
• Exceptional SAS programming skills in clinical development environments.
• Extensive CDISC SDTM/ADaM and Define.xml knowledge; FDA/ICH regulations.

Aufgaben

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and Define.xml for multiple studies.
• Develop SAS programs to generate datasets, tables, listings, figures with descriptive/inferential statistics.
• Oversee CROs' statistical programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions, DSURs and exploratory analyses.
• Contribute to creation/validation of standards for programming tools and macros.
• Collaborate with CROs and vendors to meet project timelines and goals.

Kenntnisse

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Ausbildung

Bachelor's degree in CS/Math/Stats

Tools

SAS

R

Unix/Linux

Git

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a global pharmaceutical client. You will lead SAS programming across SDTM/ADaM deliverables, develop complex listings and figures, and oversee CRO programming to ensure high quality, on-time outputs in a remote, sponsor-dedicated setting.

The role requires extensive CDISC experience, regulator-facing submission work, and strong communication and leadership abilities.