Biostatistics

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Biostatistics

Mission

To identify, develop and apply sound statistical foundations and innovative statistical methodology essential for the advancement of science at PHRI.
To ensure accurate design, implementation and maintenance of study data.

Vision

The research activities of PHRI are provided with optimal quality data, and timely, responsive, state-of-the-art statistical and methodological support.

Areas of application

Cardiovascular diseases – prevention, arrhythmias, acute coronary syndromes
Stroke and cognitive function
Cardiac and non-cardiac perioperative medicine
Diabetes
Obesity
Renal disease
Cancer
Frailty
Gastrointestinal disorders

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

Types of Work

Intervention studies
Drugs, devices, surgical interventions
Phase II-IV and registries
Clustered designs
Non-inferiority hypotheses
Epidemiologic studies – case-control, cohorts, cross-sectional

Regulatory Requirements

US FDA – STDM, ADAM datasets for Clinical Data Interchange Standards Consortium (CDISC) standards
PHRI is a proud Platinum sponsor of CDISC

Management

3
Senior Principal Biostatisticians

6
Principal Biostatisticans

3
Senior Biostatisticans

3
Biostatisticans

5
Senior Research Fellows

2
Senior Statistical Programmers

8
Senior Edit Check Programmers

4

Janice Pogue Lectureships in Biostatistics

Janice Pogue Lectureship in Biostatistics

Named for the late Janice Pogue, founder of PHRI’s Statistical group in the 1990s, the Janice Pogue Lectureship in Biostatistics showcases international leaders to share their knowledge.

Image, left to right: PHRI Statistics Director Shrikant Bangdiwala; 5th annual Pogue Lectureship Janet Wittes; Lehana Thabane, VP, Research, St. Joseph’s Healthcare; and Pogue’s widower David White – June 2022.

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.

Xiumei Yang

Associate Operations Manager

Xiumei Yang

Associate Operations Manager

xiumei.yang@phri.ca

Xiumei Yang stared to work at PHRI’s Statistics Department in 2006. With more than 17 years of service, she has obtained broad experience and training in Data Management, EDC systems, industry standards (CDISC) on clinical trial data collections and data submissions, and strong Unix and SAS programming skills.

She holds a Bachelor of Computer Science, and Big Data Analytics Certification, from McMaster University.