Remote Principal Biostatistician – Lead Trials

MMS Holdings Inc; South Africa; Sur place; ZAR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

MMS Holdings Inc. in South Africa is seeking a Principal Biostatistician to lead complex biostatistics projects and regulatory submissions. You will collaborate with sponsors, CROs, and cross-functional teams to ensure robust statistical methods and compliant analyses.

The ideal candidate has 7+ years in biostatistics, deep understanding of drug development and experience with ISS/ISE submissions, SAPs, and iSAPs, plus strong communication and leadership skills.

Qualifications

• Masters in Biostatistics, Statistics discipline or related field; PhD preferred.
• Minimum of 7 years' experience in Biostatistics or similar field.
• Submission experience (ISS/ISE).
• High level knowledge of drug development as it pertains to biostatistics.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.

Responsabilités

• Lead complex projects, programs and submissions; manages client meetings and timelines.
• Develop SAPs and iSAPs text and shells with minimal supervision.
• Prepare and review statistical methods and results sections for CSR with medical writers.
• Review or create statistical specifications; collaborate with programmers and junior statisticians.
• Provide statistical consulting to sponsors on study design and sample size.
• Guide others in a variety of biostatistical techniques and drug development knowledge.
• Support Data Safety Monitoring Boards by presenting outputs as the unblinded statistician.

Connaissances

Communication

Organization

Problem-solving

MS Office

Formation

Masters in Biostatistics / Statistics

PhD preferred

Outils

SAS

MS Office

Description du poste

MMS Holdings Inc. in South Africa is seeking a Principal Biostatistician to lead complex biostatistics projects and regulatory submissions. You will collaborate with sponsors, CROs, and cross-functional teams to ensure robust statistical methods and compliant analyses.

The ideal candidate has 7+ years in biostatistics, deep understanding of drug development and experience with ISS/ISE submissions, SAPs, and iSAPs, plus strong communication and leadership skills.