Job Category: Clinical Development, DM and Biostatistics
Requisition Number: SENIO001357
Apply now Posted: July 17, 2024Full-TimeLocationsShowing 1 location
South Africa
IAVI
Ground Floor, Collingwood Building
Black River Park
Cape Town, SA 7925, ZAF
Remote - South Africa NY Office
IAVI
125 Broad St
9th Floor
New York, NY 10004, USA
Remote - United States COVID-19 Vaccination Policy: As an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI requires 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.
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: 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.
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.Maintain biostatistics-related eTMF materials for IAVI clinical trials.Ensure CDISC/CDASH standards are applied by vendors.Oversee biostatistical workflow of IAVI-contracted CROs.Develop and review external data transfer agreements; consult with CROs to integrate external data into study programming process flow.Review SDTM and ADaM dataset specifications.Provide/facilitate support as needed to ensure efficient action, collaboration, and resolution of biostatistical issues.Assist QA team in performing vendor audits, as required.Write and revise relevant departmental Standard Operating Procedures (SOPs).Ensure compliance with departmental SOPs.Education and Work Experience: MS or MPH degree in Statistics, Biostatistics, or related field is required.Minimum 7 years of experience in the pharmaceutical industry in Biostatistics and SAS programming is required.Qualifications and Skills: Design and analysis of safety, immunogenicity, and/or efficacy endpoints for early to late-stage vaccine trials are required.Vendor oversight of programming and statistical deliverables is required.Experience with various eDC platforms and tools as applied to clinical trials is required.Proven ability to be innovative, set realistic timelines, and provide leadership as part of a clinical study project team.Experience implementing GCP guidelines is required.Attention to detail, with the ability to work on multiple projects with overlapping schedules and priorities.Excellent verbal and written communications skills.Excellent computer literacy skills with expertise in Microsoft Office are required.Organizational Overview: IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions.
IAVI CORE VALUES: Dedication to the MissionInnovative EvolutionIntegrityCollaborationCompensation and Benefits: Annual base salary for this position is: $130,000.00 - 140,000.00
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