Principal Biostatistician - Home Based (SA)

MMS; Cape Town; On-site; ZAR 1,100,000 - 1,600,000; Full time

Job summary

MMS is a data-focused clinical research organization with a global footprint. We seek a Principal Biostatistician to lead complex projects across CRO networks, bringing deep expertise in trial statistics and regulatory submissions.

Join a collaborative, innovative team in Cape Town, where your analytical leadership will shape study design, analyses, and reporting for pharma and device sponsors, while mentoring junior statisticians.

Qualifications

• Masters in Biostatistics or related field; PhD preferred.
• Minimum of 7 years’ experience in Biostatistics or similar field; ISS/ISE submission experience.
• High level knowledge of drug development as it pertains to biostatistics.
• Excellent problem-solving and communication skills.
• Familiarity with ISO 9001 and ISO 27001 standards; 21 CFR Part 11, FDA, and GCP familiarity.

Responsibilities

• Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates with regulatory, PMs and sponsors.
• Develop SAPs and iSAPs text and shells with supervision.
• Produce and present external company presentations providing industry visibility for the organization; suggest solutions in line with organizational direction.
• Review or develop ADAM specifications; work with programmers and junior statisticians to resolve comments.
• Act as Subject Matter Expert in biostatistics; guide others in various biostatistical techniques.
• Apply drug development knowledge during production of complex statistical analyses.
• Review or create statistical sections of Sponsor's protocol and provide feedback on statistical methods.
• Prepare and review statistical methods and results sections for the CSR with in-house medical writers.
• Demonstrate understanding of project management tasks such as timelines, scope and resource estimation.
• Perform sample size calculations for diverse designs; provide statistical consulting on study design.
• Create randomization and kit schedules; collaborate with sponsor and drug supply teams.
• Understand tools used (SCM, SharePoint) and use them correctly.
• Provide support to DSMB as unblinded statistician.
• Stay current with latest industry practices and regulatory guidelines.
• Write blogs/white papers for company website.

Skills

Biostatistics

Regulatory knowledge

Communication skills

Clinical trials

CRO knowledge

MS Office

Problem solving

GCP familiarity

Quality standards

Education

Masters in Biostatistics

PhD preferred

Tools

SharePoint

ADAM specifications

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 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.

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.

Principal Biostatistician

Roles And Responsibilities

• Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors
• Can develop SAPs and iSAPs text and shells with no supervision
• Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction
• Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments
• High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques
• Has the ability to apply drug development knowledge during production of complex statistical analyses
• Review or create the statistical section(s) of a Sponsor's protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study
• Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers
• Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management
• Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations
• Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams
• Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)
• Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines
• Write blogs and/or white papers for posting on the company website

Requirements

• Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred
• Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required
• Submission experience (ISS/ISE)
• Has high level knowledge of drug development as it pertains to biostatistics
• Expert knowledge of scientific principles and concepts.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Good organizational skills
• High proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Excellent problem-solving skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Good 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.