Senior Manager, Biostatistics

As an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment. 

Position Description  

Job Title:         Senior Manager, Biostatistics
Location:        Cape Town, South Africa; South Africa, Remote; New York, NY, or US-Remote
Reports to:     Director, Biostatistics 

Position Summary: 

Are you an experienced and ambitious Biostatistician who is eager to make an impact on global public health?

IAVI is seeking a Senior Manager, Biostatistics who will lead and oversee Contract Research Organization (CRO) vendors for IAVI Biostatistical & programming activities, in support of Phase I through IV clinical trials. The Sr. Manager will serve as a member of the Clinical Development department and will provide guidance to the CD team regarding trial design, endpoint selection, statistical analysis, and vendor selection for IAVI’s clinical trials. The Sr. Manager will also manage timelines relating to key milestones and ensure outsourced work is performed with high quality.

Key Responsibilities:

• Provide oversight of outsourced biostatistical activities, coordination with other functional areas, and management of overall timelines, resources, and quality.
• Oversee biostatistics and programming-related activities, including sample size and power calculation, protocol development, trial start-up, randomization specifications, case report form (CRF) development, statistical analysis plan (SAP) and table shells development for interim and final analyses, statistical programming, safety reporting, Clinical Data Interchange Standards Consortium (CDISC) compliance, and all associated documentation for electronic trial master file (eTMF) filing.
• Act as a liaison between biostatistics vendors and the CD team, in particular Medical Monitors, Clinical Operations, and Data Management, by providing guidance on biostatistical aspects of clinical trials, such as randomization, CRF design, SAP development, safety reporting, resourcing, timelines, metrics, and other biostatistical support.
• Maintain biostatistics-related eTMF materials for IAVI clinical trials.
• Ensure CDISC/CDASH standards are applied by vendors and maintain a global CRF library appropriate for all IAVI clinical trials.
• Oversee biostatistical workflow of IAVI-contracted CROs to maximize efficiency across all clinical trial biostatistics-related deliverables.
• Develop and review external (third party) data transfer agreements; …