Senior Statistical Programmer - South Africa (Remote)

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

Job summary

A leading clinical research organization in South Africa is seeking a Senior Statistical Programmer to generate clinical trial data reports, lead programming teams, and ensure compliance with standards. The ideal candidate holds a Master's degree and has at least 5 years of experience in statistical programming. You will be part of an innovative team focused on improving clinical research outcomes and must possess strong communication and problem-solving skills.

Qualifications

• Minimum of 5 years’ experience in Statistical Programming or similar field.
• Expert knowledge of scientific principles and concepts.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others.

Responsibilities

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

Skills

SAS programming

MS Office applications

SDTM standards

ADaM standards

Leadership in programming project teams

Education

Master's degree in Statistics or related field

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 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.

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

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.