Statistical Analysis and Biometric Programming

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Statistical Analysis and Biometric Programming

The mission of the PHRI Statistics Department is to provide solid study design options and a robust and reliable data platform, which ensures that complete and accurate data are collected and maintained, allowing for sound statistical foundations and innovative statistical methodology to be identified, developed and applied.

As well, our department identifies, develops and applies sound statistical foundations and innovative statistical methodology.

The work of our statistical analysts and biometric programmers covers the full range from research study planning, through study conduct, close-out and subsequent publications.

Director, Statistics

1
Manager, Statistical Operations

1
Statisticians

14
Biometric Programmers

11
Statistical Coordinators

4
Junior Scientists

2

Study Conduct

Study conduct reporting (recruitment, data quality, adherence, compliance, outcomes, adjudication tracking, AEs/SAEs, etc.)
Data transfers to external parties
Central Statistical Monitoring
Emergency unblinding
Randomization irregularity resolution
Data Safety Monitoring Board reporting (DSMB)
Statistical Analysis Plan (SAP) development
Communicate with sponsors and/or external statisticians for data reconciliation or analysis validation

Study Planning

Consult on, and draft, statistical methods as per study design and research hypotheses for grants and/or protocols
Provide sample size and power calculations
Determine scope of work and budget for statistics resources

Study Close-Out

Additional data quality reports to ensure critical variables for analysis are clean
SAP finalization
Final analysis and unblinding of study results to Principal Investigator
Provide methods section, analysis and critical statistical review of main publication

Subsequent Publications

Review proposals
Develop SAP
Conduct appropriate analyses
Draft methods section and critically review manuscript

graph of history of PHRI Statistics department

Janice Pogue Lectureship in Biostatistics

Named for the late Janice Pogue, founder of PHRI’s Statistical group, the Janice Pogue Lectureship in Biostatistics series invites international leaders to share their knowledge. Shown here is the 3rd annual lecturer, Professor Lisa LaVange, with Shrikant Bangdiwala, Director, Statistics, PHRI.

Watch 4th Annual Janice Pogue Lectureship: Monica Taljaard, University of Ottawa Watch Co-Lecturer, PHRI Stats Coordinator Shun Fu Lee

Key Team Members

Shrikant Bangdiwala

Director, Statistics; Senior Scientist

Shrikant Bangdiwala

Director, Statistics; Senior Scientist

Shrikant.Bangdiwala@phri.ca

Shrikant Bangdiwala, PhD, has extensive experience in the design, conduct and analysis of multi-center observational and experimental studies, having worked on clinical and community-based randomized controlled trials in congestive heart failure, cardiovascular risk factors, functional bowel disease, and obesity prevention. His statistical research interests include non-parametric methods, methodology for clinical trials, reliability and validity of diagnostic tests, and graphical methods for descriptive analyses.

A Professor in McMaster University’s Department of Health Research Methods, Evidence and Impact, he is a former Fulbright senior specialist in global public health, and holds faculty positions in universities in Chile, South Africa and India.

He is a member of the USA NIH National Institute of Allergy and Infectious Diseases (NIAID) “COVID-19 Preventive mAb Data and Safety Monitoring Board” (DSMB) that will be reviewing and monitoring the US government-supported clinical trials of candidate preventive monoclonal Antibodies for SARS-CoV-2 and COVID-19. He also chairs the Multinational DSMB for the division of AIDS at NIH, and is a member of the Gastrointestinal Drugs Advisory Committee of the FDA.

Leanne Dyal

Manager, Statistical Operations

Leanne Dyal

Manager, Statistical Operations

leanne.dyal@phri.ca

Leanne Dyal is responsible for leading the development of data quality standards and processes across PHRI in accordance with industry standards. She was previously Manager, Data Management, and before that, Statistical Analyst with PHRI for several years, giving her a wealth of experience in, and knowledge of, study design, conduct, databases and data management.

She received her Bachelors of Science degree in Mathematics and Statistics, and Masters of Science Degree in Statistics, from McMaster University.