Scholarly Journals Editorial Coordinator / Assistant

Faircape Group; Wes-Kaap; Remote; ZAR 200,000 - 300,000; Full time

Job summary

Join a forward-thinking company as a Senior Statistical Programmer, where your expertise in SAS and statistical analysis will shape the future of clinical research. This role offers the opportunity to lead programming projects, generate critical data outputs, and collaborate with a talented team in a supportive environment. You'll work with cutting-edge methodologies in a globally recognized organization that values innovation and employee growth. If you're passionate about making a difference in the pharmaceutical and biotech industries, this is the perfect opportunity for you to advance your career and contribute to meaningful projects.

Qualifications

• 5+ years of experience in Statistical Programming or similar field.
• Mastery in generating tables and graphs from clinical trial databases.

Responsibilities

• Lead programming project teams and deliverables using SAS.
• Ensure compliance with E-Submission Standards and ICH guidelines.

Skills

SAS Programming

Statistical Analysis

Problem-Solving Skills

Communication Skills

Organizational Skills

Education

Masters in Statistics

Tools

SAS Base

SAS Macros

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 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 or follow MMS on [insert link].

Senior Statistical Programmer

Job Specific Skills:

• Mastery and training in 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 training on SDTM standards including the ability to write specifications.
• Advanced knowledge of ADaM standards including supporting specification writing.
• Proficient with MS Office applications.
• Advanced knowledge of ICH, 21 CFR 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 a similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as an emerging leader in the 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, and the drug development process.

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