Biostatistician - Home Based (SA)

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 www.mmsholdings.com or follow MMS on LinkedIn.

Biostatistician:

Responsibilities: 

• Contributes to Randomization and kit schedule generation; works with mentor to understand process.
• Can develop easy/standard complexity SAPs with some supervision/mentorship. can contribute to specific sections of the SAPs with some mentorship.
• Can review and develop ADaM specifications and datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Develops strong programming and logic skills.
• Can work along a more senior biostatistician to provide output review and work with programmers to address findings.
• Can contribute to generating simple sample size calculations using relevant software under mentor supervision.
• Can organize CRMs for addressing easy/standard complexity studies' comments; can work with the senior biostatistician to understand and address comments on other more complex studies.
• Has good knowledge of CDISC requirements (especially ADaM).
• Can contribute to department initiatives, provide feedback on SOPs and other department processes and documents.
• Proficiency with MS office applications and able to develop clean documents that require minimal updates.
• Demonstrate understanding of ICH guidelines as applicable to statistics.
• Prepare and review statistical methods and results sections for the CSR with some supervision in collaboration with in-house medical writers.

Requirements:

• College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.
• Minimum of 2 years’ experience in Biostatistics or similar field required.
• Expert knowledge of scientific principles and concepts.
• 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.

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