Senior Statistical Programmer

MMS Holdings Inc.; Remote; ZAR 60 000 - 80 000; Full time

Job summary

A prominent clinical research organization in Gauteng seeks a Senior Statistical Programmer to generate critical trial data insights. You will use advanced SAS programming skills and contribute to clinical projects to enhance data submissions in compliance with industry standards. The ideal candidate will have a Master's degree in Statistics and a minimum of 5 years' experience in statistical programming. Join a supportive team committed to innovative solutions in clinical research and enjoy excellent organizational culture.

Qualifications

• Minimum of 5 years’ experience in Statistical Programming or similar field.
• Hands-on experience with clinical trial and pharmaceutical development is preferred.
• Proficient communication skills and problem-solving skills.

Responsibilities

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Utilize SDLC for programming deliverables.
• Lead study or small programming project teams.

Skills

SAS programming

SDLC

ADaM standards

E-Submission Standards

MS Office applications

BIMO outputs

SDTM standards

Education

Masters in Statistics

Job description

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 a 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 trained on 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 trained on SDTM standards including ability to write specifications.
• Advanced knowledge of ADaM standards including supporting specification writing.
• Proficient with MS Office applications.
• Advanced knowledge of ICH, 21CRF 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.

Job Requirements

• 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 emerging leader in 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, & the drug development process.

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