Senior Statistical Programmer - South Africa (Remote) Biometrics SOUTH AFRICA
Job details
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Senior Statistical Programmer Job Specific Skills:
- Mastery and training in generating tables, listings, and graphs from clinical trial databases using SAS.
- Utilizes System Development Life Cycle (SDLC) for programming deliverables.
- Advanced user in SAS programming, SAS Base, and SAS Macros.
- Advanced knowledge of E-Submission Standards, Guidelines, and Regulations.
- Mastery and training on SDTM standards including the ability to write specifications.
- Advanced knowledge of ADaM standards including supporting specification writing.
- Proficient with MS Office applications.
- Advanced knowledge of ICH, 21 CFR Part 11, and ISO 9001:2000 requirements.
- Advanced experience with pooling of data sets for submissions.
- Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
- Lead study or small programming project teams.
- Masters required for all Statistics roles.
- Minimum of 5 years’ experience in Statistical Programming or similar field required.
- Expert knowledge of scientific principles and concepts.
- Reputation as an emerging leader in the field with sustained performance and accomplishment.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
- Basic understanding of CROs and scientific & clinical data/terminology, and the drug development process.
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