Senior Statistical Programmer (Remote) — SDTM/ADaM Lead

Deviare

South Africa

Remote

ZAR 900,000 - 1,200,000

Full time

3 days ago
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Job summary

Parexel is seeking a Senior Statistical Programmer (FSP) to join our team in South Africa, dedicated to a single sponsor.

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data.

Qualifications

  • Educated to degree level in a relevant discipline or equivalent work experience.
  • Competent in written and oral English.
  • Knowledge of ICH-GCP, SOPs and regulatory inspections including 21 CFR Part 11.
  • Ability to learn new systems and function in an evolving technical environment.
  • Strong attention to detail and accuracy in programming outputs.

Responsibilities

  • Provide technical expertise for the conduct of clinical trials.
  • Lead statistical programming timelines and coordinate a team on projects.
  • Review SAPs and database set-up specifications.
  • Interact with sponsors and internal stakeholders on programming issues.
  • Maintain supporting documentation per SOPs and guidelines to ensure traceability and compliance.

Skills

Excellent analytical skills
Programming & reporting process
ICH-GCP & 21 CFR Part 11
Global team collaboration
Time management
Attention to detail
Learning new systems

Education

Degree in a relevant discipline

Job description

Parexel is seeking a Senior Statistical Programmer (FSP) to join our team in South Africa, dedicated to a single sponsor.

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data.

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