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.

Kumar Balasubramanian

Statistical Operations Manager

Kumar Balasubramanian

Statistical Operations Manager

kumar.balasubramanian@phri.ca

Kumar Balasubramanian has been an integral part of the PHRI Statistics department since November 2013 when he joined as a Statistical Analyst; then became Statistical Analyst II in 2016, and Statistical Coordinator in 2018. In August 2021 he became the department’s Statistical Operations Manager.

Before coming to PHRI, Kumar held academic statistical positions at University of Calgary and University of Toronto. He holds a Masters in Biostatistics from University of Toronto.