Senior Statistical Programmer - South Africa (Remote)

MMS Holdings Inc.; Pretoria; Remote; ZAR 50 000 - 90 000; Full time

Job summary

Join a forward-thinking company that values your contributions and offers a supportive, innovative environment. As a Senior Statistical Programmer, you will play a crucial role in shaping the future of clinical research through your expertise in SAS programming and statistical analysis. Collaborate with a dedicated team to tackle complex challenges in clinical trials and regulatory submissions. This is an exciting opportunity to advance your career in a data-focused organization recognized for its exceptional culture and employee satisfaction. If you're passionate about making an impact in the pharmaceutical and biotech industries, this role is perfect for you.

Qualifications

• Master's degree required for all Statistics roles.
• At least 5 years of experience in Statistical Programming or a related field.

Responsibilities

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

Skills

SAS Programming

Statistical Analysis

Communication Skills

Problem-Solving

Organizational Skills

Education

Master's Degree in Statistics

Tools

SAS Base

SAS Macros

MS Office

Job description

Job Description: Senior Statistical Programmer

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 [insert platform].

Key Responsibilities:

• Master and generate tables, listings, and graphs from clinical trial databases using SAS.
• Utilize the System Development Life Cycle (SDLC) for programming deliverables.
• Demonstrate advanced proficiency in SAS programming, including SAS Base and SAS Macros.
• Maintain advanced knowledge of E-Submission Standards, Guidelines, and Regulations.
• Master SDTM standards and write specifications accordingly.
• Support ADaM standards and contribute to supporting specification writing.
• Proficiently use MS Office applications.
• Apply advanced knowledge of ICH, 21 CFR Part 11, and ISO 9001:2000 requirements.
• Pool datasets for submissions with advanced expertise.
• Generate BIMO outputs, define.xml, Reviewer's Guides, and SDSP.
• Lead study or small programming project teams.

Minimum Requirements:

• Master's degree required for all Statistics roles.
• At least 5 years of experience in Statistical Programming or a related field.
• Expertise in scientific principles and concepts.
• Recognized as an emerging leader with sustained performance.
• Proficiency with MS Office applications.
• Preferred experience with clinical trials and pharmaceutical development.
• Strong communication skills and collaborative problem-solving abilities.
• Excellent organizational skills.
• Familiarity with ISO 9001 and ISO 27001 standards is a plus.
• Knowledge of 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CRO operations, scientific and clinical data, and drug development processes.

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