Senior Biostatistician: Clinical Trials & Submissions Lead

Cytel; Cape Town; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel in Cape Town, South Africa seeks a Senior Biostatistician to support or lead Phase I–IV clinical studies, performing analyses, contributing to study design, SAPs and submissions, and collaborating with CROs and vendors.

The ideal candidate has a Master’s in statistics (Ph.D. preferred), 5+ years in pharmaceutical/biotech trials, strong SAS and R skills, CDISC ADaM experience, and excellent communication for regulatory interactions.

Qualifications

• Master’s degree in statistics or a related discipline.
• Ph.D. as a strong plus.
• 5+ years in clinical trials within Pharma/Biotech.
• Experience with regulatory submissions and CDISC standards.

Responsibilities

• Provide statistical support for clinical studies and submissions.
• Develop SAPs, analysis datasets, and TLG specifications.
• Review CRFs and data review guidelines; perform analyses and interpret results.
• Prepare clinical study reports and integrated summaries for submissions.
• Collaborate with CROs, vendors, and internal teams to meet project timelines.

Skills

SAS programming

R programming

CDISC ADaM

Statistical analysis

Regulatory submissions

Strong communication

Education

Master’s in statistics or related discipline

PhD preferred

Tools

SAS

R

CDISC ADaM

Job description

Cytel in Cape Town, South Africa seeks a Senior Biostatistician to support or lead Phase I–IV clinical studies, performing analyses, contributing to study design, SAPs and submissions, and collaborating with CROs and vendors.

The ideal candidate has a Master’s in statistics (Ph.D. preferred), 5+ years in pharmaceutical/biotech trials, strong SAS and R skills, CDISC ADaM experience, and excellent communication for regulatory interactions.