Senior Principal Statistical Programmer - SAS + R (Remote)

Bconsult | Skills Development Partner For South African Businesses; Cape Town; Remote; ZAR 1.983.000 - 2.644.000; Vollzeit

Zusammenfassung

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely within our sponsor-dedicated team. You will implement reporting and analysis for multiple clinical studies and oversee CRO programmers to ensure high-quality data deliverables.

The role focuses on SDTM/ADaM development, regulatory submissions, and adherence to FDA/ICH guidelines, with opportunities to influence trial data strategies in a global setting.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in developing and implementing statistical programming procedures in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Ability to work independently.
• Outstanding written and verbal communication skills and strong leadership.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and Define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and complex graphs.
• Deliver high-quality statistical programming results with SAS and/or R.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and exploratory analyses.
• Follow FDA regulations and guidelines for electronic submissions.

Kenntnisse

Independent work

Written and verbal communication

Leadership

Regulatory submissions experience

FDA/ICH regulations knowledge

Ausbildung

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

Tools

SAS

R

CDISC SDTM/ADaM

Define.xml

Unix/Linux

Git

Python

Jobbeschreibung

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely within our sponsor-dedicated team. You will implement reporting and analysis for multiple clinical studies and oversee CRO programmers to ensure high-quality data deliverables.

The role focuses on SDTM/ADaM development, regulatory submissions, and adherence to FDA/ICH guidelines, with opportunities to influence trial data strategies in a global setting.