Lead Biostatistician: Drive Complex Trials & Submissions

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

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.