Senior Statistical Programmer - South Africa (Remote)

MMS Holdings Inc.; Cape Town; Remote; ZAR 600 000 - 900 000; Full time

Job summary

Join a leading clinical research organization as a Senior Statistical Programmer in Cape Town. This role requires mastery in SAS programming and a Master's degree, with a focus on generating clinical trial data outputs and ensuring compliance with industry standards. The ideal candidate will have at least 5 years of experience and strong leadership skills, contributing to innovative projects in a collaborative environment.

Qualifications

• Minimum of 5 years’ experience in Statistical Programming or a related field.
• Hands-on experience with clinical trials and pharmaceutical development preferred.

Responsibilities

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Utilizes System Development Life Cycle (SDLC) for programming deliverables.

Skills

SAS

Statistical Programming

Communication

Problem Solving

Leadership

Education

Master's degree

Tools

MS Office

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 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-leading 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 maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team shaping the future of clinical research.

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

Senior Statistical Programmer

Job Specific Skills :

1. Mastery and training in generating tables, listings, and graphs from clinical trial databases using SAS.
2. Utilizes System Development Life Cycle (SDLC) for programming deliverables.
3. Advanced proficiency in SAS programming, SAS Base, and SAS Macros.
4. In-depth knowledge of E-Submission Standards, Guidelines, and Regulations.
5. Mastery and training on SDTM standards, including the ability to write specifications.
6. Advanced knowledge of ADaM standards, including supporting specification writing.
7. Proficient with MS Office applications.
8. Strong understanding of ICH, 21 CFR Part 11, and ISO 9001:2000 requirements.
9. Extensive experience with pooling datasets for submissions.
10. Experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
11. Leadership experience in study or small programming project teams.

Job Requirements :

1. Master's degree required for all Statistics roles.
2. Minimum of 5 years’ experience in Statistical Programming or a related field.
3. Expert knowledge of scientific principles and concepts.
4. Reputation as an emerging leader with sustained performance and accomplishments.
5. Proficiency with MS Office applications.
6. Hands-on experience with clinical trials and pharmaceutical development preferred.
7. Good communication skills and willingness to collaborate effectively.
8. Excellent problem-solving skills.
9. Strong organizational and communication skills.
10. Familiarity with ISO 9001 and ISO 27001 standards preferred.
11. Knowledge of 21 CFR Part 11, FDA regulations, and GCP requirements.
12. Basic understanding of CRO operations, scientific and clinical data, and drug development processes.

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

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Senior Statistical Programmer • Cape Town