Senior Statistical Programmer - South Africa (Remote)
MMSWorkFromHome, Western Cape, South Africa1 day ago
Job type
- Remote
Job descriptionMaster’s degree required. Minimum of 5 years’ experience in Statistical Programming or a related field. Expert knowledge of scientific principles and concepts. Emerging leader with sustained performance and accomplishments. Proficiency with MS Office applications. Hands‑on experience with clinical trial and pharmaceutical development preferred. Strong communication skills and ability to collaborate to solve problems. Excellent problem‑solving skills. Good organizational and communication skills. Familiarity with ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and the drug development process.
Senior Statistical Programmer - South Africa (Remote)
MMS is an award‑winning, data‑focused clinical research organization that supports the pharmaceutical, biotech, and medical device industries across four continents.
Job Overview
We are looking for a senior statistical programmer to generate tables, listings, and graphs from clinical trial databases using SAS and support regulatory submissions, operating within the System Development Life Cycle (SDLC).
Job Specific Skills
- Mastery in generating tables, listings, and graphs from clinical trial databases using SAS.
- Proficient in SAS Base, SAS Macros, and advanced SAS programming.
- Advanced knowledge of E‑Submission Standards, Guidelines and Regulations.
- Mastery of SDTM standards and experience writing specifications.
- Advanced knowledge of ADaM standards and supporting specification writing.
- Proficient with MS Office applications.
- Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001 : 2000 requirements.
- Experience with pooling of data sets for submissions.
- Experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
- Lead study or small programming project teams.
Job Requirements
Should you not receive a response within 14 days of application, your application may be considered unsuccessful.
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