# Data Management & Statistical Core

> **NIH NIH U54** · H. LEE MOFFITT CANCER CTR & RES INST · 2024 · $39,545

## Abstract

PROJECT SUMMARY – DATA MANAGEMENT & STATISTICS CORE
The overarching goal of the Data Management & Statistics Core (DMSC) for the Partnership to Assess Viral and
Immune Landscape Intersections with Oncology for People Living with HIV (PAVILION) is to provide
comprehensive statistical design, data management, and analysis in support of conducting rigorous and
reproducible research by PAVILION investigators who are working to make strides in understanding the
proportion of tumors whose etiology is attributable to the human papillomavirus (HPV) and Epstein-Barr virus
(EBV) among people living with HIV in sub-Saharan Africa including such rare tumor types as anal, cervical,
conjunctival, oropharyngeal, penile, and vulvar cancers. The DMSC will be led by Dr. Michael Schell, who is
exceptionally qualified in the design, analysis, and management of clinical and epidemiological studies. The
DMSC has designed a robust yet flexible pipeline that builds upon the extensive infrastructure and long-term
international collaborations established by the PAVILION partnering investigators including those of the HIM1,
BROADEN2, and EVRI3 international study teams. It leverages the extensive investment by Moffitt Cancer Center
in biostatistics, bioinformatic, informatic, and computing capabilities as well as the depth and breadth of expertise
in the analysis of basic, translational, clinical, and large-scale cancer epidemiological studies to address project
aims and build biostatistical capacity at Stellenbosch University (South Africa) and University of Zimbabwe, the
PAVILION low- and middle-income country (LMIC) sites. Further, the DMSC will provide education and training
through lectures and mentorship in biostatistics to members and research staff, with the goal of building the
expertise and capacity of the LIMC partner sites to lead future studies/trials. To achieve the overarching goal,
the DMSC will provide statistical and analytical design, sample size determination, continuous monitoring of
accumulating data, statistical analysis of results, and manuscript development for peer reviewed publication.
These activities are organized into the following Specific Aims:
Aim 1: Provide statistical support for the design, conduct, and data management of planned and future
PAVILION studies This aim provides support for the initial experimental design and data accumulation phases
of the proposed and future PAVILION projects.
Aim 2: Lead statistical analysis of data produced by PAVILION studies for peer reviewed publication
This aim provides hands on statistical support for analyzing downstream data produced by the proposed
translational research projects and any pilot projects awarded through the Developmental Core.
Aim 3: Educate and train investigators at PAVILION LMIC partnering sites on biostatistical methods and
resources needed for large scale epidemiological studies This aim provides hands on mentorship of two
early career biostatisticians in South Africa and Zimb...

## Key facts

- **NIH application ID:** 10898564
- **Project number:** 5U54CA277834-02
- **Recipient organization:** H. LEE MOFFITT CANCER CTR & RES INST
- **Principal Investigator:** MICHAEL JOSEPH SCHELL
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $39,545
- **Award type:** 5
- **Project period:** 2023-08-03 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10898564

## Citation

> US National Institutes of Health, RePORTER application 10898564, Data Management & Statistical Core (5U54CA277834-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10898564. Licensed CC0.

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