Senior Statistical Programmer - Remote Lead, Clinical Data

Placements24; Mbombela (Nelspruit); À distance; ZAR 1 983 000 - 2 809 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to drive SDTM/ADaM development for global pharmaceutical studies.

You will implement reporting and analysis activities across sponsor trials, mentoring CRO programmers, and ensuring data quality and timely delivery. The role requires 7+ years of pharmacometric programming experience, expert SAS skills, CDISC standards mastery, and strong communication with regulators.

Qualifications

• Must have 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Strong SAS programming skills with experience in clinical development environments.
• Extensive CDISC standards knowledge (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interacting with regulatory authorities.
• Ability to work independently and lead others with excellent communication.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality programming results and maintain SAS and/or R programs for clinical programs.
• Oversee CRO statistical programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR.
• Create and follow standards for programming tools, outputs, and macros.

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to drive SDTM/ADaM development for global pharmaceutical studies.

You will implement reporting and analysis activities across sponsor trials, mentoring CRO programmers, and ensuring data quality and timely delivery. The role requires 7+ years of pharmacometric programming experience, expert SAS skills, CDISC standards mastery, and strong communication with regulators.