Senior Biostatistician (Home Based - South Africa)

MMS Holdings Inc.; Johannesburg; On-site; ZAR 500,000 - 600,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Biostatistician in Johannesburg, South Africa. The ideal candidate will have a Master's or PhD in Statistics and relevant experience in the pharmaceutical industry. Responsibilities include developing statistical analysis plans, reviewing datasets, and ensuring data quality throughout clinical trials. Join a collaborative team and contribute to the future of clinical research.

Qualifications

• Master's or PhD in Statistics required.
• 4+ years experience in relevant field or 2+ years with PhD.
• Experience in the pharmaceutical industry recommended.

Responsibilities

• Develop and review statistical analysis plans.
• Provide input into the statistical sections of clinical protocols.
• Perform senior-level reviews of datasets.

Skills

SAS

Statistical analysis

Mathematical skills

Problem-solving skills

Project coordination

Communication skills

Teamwork

Education

Master of Science in Statistics

PhD in Statistics

Tools

MS Office (Excel, Word, PowerPoint)

EDC systems

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 Biostatistician :

Roles & Responsibilities

• Provide input into statistical sections and overall consistency of clinical study protocols.
• Develop and review statistical analysis plans (SAP). Determine appropriate analyses for clinical endpoints based on input from the protocol and the client.
• Perform senior-level reviews and be responsible for datasets and outputs of a project. Ensure consistency with the SAP and review for correctness and quality.
• Work with programming team to provide input for analysis / ADaM datasets to be used for final analyses. Develop specifications and review datasets based on planned tables, listings, and graphs (TLGs).
• Prepare TLG shells / specifications and programming notes based on SAP and analysis / ADaM datasets.
• Collaborate with data management team to review data collection (e.g., CRFs) and help ensure data quality throughout the clinical trial.
• Coordinate the preparation, execution, reporting, and documentation of high-quality statistical analyses according to the SAP.
• Provide high-level support to programmers and medical writers on all statistical matters according to client requirements.
• Prepare and review statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Generate sample size calculations appropriate for the primary endpoint based on input from the protocol.
• Generate and review randomization schedules per the protocol and randomization specifications.
• Work with the project management team to ensure timelines are appropriate given the scope of the project.
• Stay current with the latest industry practices and updated regulatory guidelines.
• Communicate competently and independently with clients to coordinate statistical and programming considerations.
• Demonstrate strong understanding of ICH guidelines as applicable to statistics.
• Practice good internal and external customer service.

Requirements

• Master of Science (or equivalent) in statistics with four (4) or more years of relevant work experience, or PhD (or equivalent) in statistics with at least two (2) years of relevant experience.
• Strong knowledge and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS / ODS, SAS / Graph).
• Hands-on experience with SAS to validate datasets and outputs by digging into data.
• Excellent mathematical and problem-solving skills.
• Advanced knowledge of statistical considerations in drug development, including hands-on experience with clinical trial data.
• Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis, imputation methods, descriptive statistics).
• Familiarity with clinical data and databases, including EDC systems.
• Working knowledge of SDTM / ADaM standards or experience working with analysis or derived datasets.
• At least three (3) years of experience in the pharmaceutical industry.
• Ability to coordinate analytical aspects of multiple projects or trials simultaneously.
• Proficiency with MS Office applications (Word, PowerPoint, Excel).
• Good interpersonal, oral, and written communication skills.
• Self-motivated, dependable, positive team-oriented personality.
• Ability to communicate effectively and provide clear directions to Statistical Programmers.

Please consider your application unsuccessful if we do not contact you within 14 days of submission.