Statistical Programmer II - South Africa (Home Based)

Full Time

Biometrics

Experienced

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.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Statistical Programmer II

Job Specific Skills:

Proficient generating tables, listings, and graphs from clinical trial databases using SAS.
Utilizes System Development Life Cycle (SDLC) for programming deliverables.
Proficient in SAS programming, SAS Base, SAS Macros.
Ability to adhere to E-Submission Standards, Guidelines and Regulations.
Mastery of SDTM standards including ability to write specifications.
Proficient in ADaM standards.
Proficient with MS Office applications.
Ability to adhere to 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.
Member of project team.

Requirements:

Masters required for all Statistics roles.
Minimum of 3 years’ experience in Statistical Programming or similar field required.
Expert knowledge of scientific principles and concepts.
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, & the drug development process.

Should you not have received a response within 14 days of your application, please consider your application unsuccessful.

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Statistical Programmer II - South Africa (Home Based)

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