Principal Statistical Programmer (Remote) - SAS + R Lead

Placements24

South Africa

Remote

ZAR 900,000 - 1,400,000

Full time

5 days ago

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Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to be remotely embedded with a global pharmaceutical client. You will develop SDTM/ADaM specs, SAS programs, listings, tables and graphs, and oversee CRO programming deliverables to ensure high quality and on-time delivery.

In this role you will work with regulatory submissions, contribute to study reports and... (truncated for length in this JSON).

Qualifications

Bachelor's degree in CS/DS/Math/Stats preferred.
7+ years experience as Statistical Programmer in Biotech/Pharma Biometrics.
Exceptional SAS programming skills in clinical development.
CDISC SDTM/ADaM and Define.xml experience.
Experience supporting regulatory submissions and FDA interactions.
Ability to work independently with strong communication and leadership.

Responsibilities

Generate SDTM, ADaM specs, datasets, reviewer's guide and Define.xml for multiple studies.
Develop SAS programs to create datasets, tables and graphs for analyses.
Deliver high-quality SAS and R programs for clinical development programs.
Oversee CRO programming deliverables to ensure quality and timelines.
Support preparation of clinical study reports, regulatory submissions and publications.
Follow FDA regulations and GCP for electronic submissions.
Contribute to standards for programming tools, outputs and macros.