Biostatistics & Study Design


Spectrum provides assistance to investigators for designing clinical trials through the Center for Innovative Study Design (CISD).

Services Provided
  • Pre-award & post-award support
  • Study design assistance
  • Advice on setup of data management
  • Training in study design, statistical analysis, use of data tools
Schedule a consultation

Email a consultant; see "Next Steps"


Overview of the Biostatistics & Study Design Program

Spectrum provides assistance to investigators for designing clinical trials through the Center for Innovative Study Design (CISD) which is housed in Health Research and Policy.

CISD staff is available to individual investigators pre-award to foster and improve the initial planning and design of studies. Its primary function is to assist investigators in formulating their scientific problems in statistical terms, and to align their experimental design, data collection, and analysis plans with their scientific aims.

The staff also assists with post-award advice on setup of data management, working with Spectrum programs.

CISD staff participates in training clinical researchers and their staff in design of studies, statistical analysis, and the use of data visualization and exploration tools.

The operating core of the CISD consists of the HRP biostatistics faculty and academic staff biostatisticians, and key individuals from the faculty of other departments in the School of Medicine and the Statistics Department in the School of Humanities and Sciences.

CISD Grand Aim

In addition to its general collaborative role in research at Stanford, the CISD is oriented toward a transformative ‘grand aim’ – to fully integrate the tools of statistical design into the practice of medicine, helping to advance drug development and create a system of health care that is capable of automatic knowledge-driven improvement at a much faster pace. Besides methodological development toward this aim, the CISD also develops software and computational tools to implement the innovative design and analysis methods developed. It also organizes periodic conferences and short courses to disseminate and discuss recent research findings and developments.

Biostatistics & Study Design — Information & Consultations

The Stanford Center for Clinical and Translational Education and Research (Spectrum), in association with the Department of Biomedical Data Science, offers a free one-hour consultation on study design.

Find out more about the services offered by the Department of Biomedical Data Science, including help on a grant application or study protocol (design, statistical plans, power and sample size, database design).

Discussion topics of interest include:

  • Statistical design, sample size and power
    (Consultants: McMillan, Narasimhan, Tamaresis)
  • Statistical analysis of preliminary data (limited availability)
    (Consultants: McMillan, Tamaresis)
  • Other data management issues (e.g. validation) – data entry services not available
  • Advice on analyzing data
    (Consultants: McMillan, Tamaresis)
  • Statistical analysis of data (limited availability)
    (Consultants: McMillan, Tamaresis)
  • Formulating a statistical analysis plan
    (Consultants: McMillan, Narasimhan, Tamaresis)
  • Organizing your data for capture into a database
  • Statistical support for Data Safety Monitoring Board (limited availability)
  • Advice on responding to journal review
    (Consultants: McMillan, Narasimhan, Tamaresis)
  • Help in designing a cancer clinical protocol
    (Consultants: McMillan, Narasimhan, Tamaresis)

Prior to your appointment:

Next Steps

Study Design Workshop

Data Studio brings together biomedical researchers and biostatistics faculty for in-depth consultations about clinical trials, epidemiological/population health studies, and complex panomics studies. Our facilitator assists the biomedical researcher to prepare the data, statistical questions, and other materials for the consultation. Click here to find out more about the Data Studio.

The Center for Innovative Study Design (CISD)

The Center for Innovative Study Design (CISD) was created in March 2009 to integrate the following services in the School of Medicine:

  • Data Coordinating Center (designs and implements specialized, innovative clinical study data and management and visualization tools)
  • Biostatistics Shared Resource of the Stanford Cancer Institute
  • Biostatistics and Design Program of Spectrum
  • Design and review capacity of the Clinical and Translational Research Unit (CTRU)
  • Clinical and translational research (CTR) offerings in pre-award design consultation service

CISD provides training, workshops, and expert consultation and planning in clinical research informatics.

For complete information on the services available visit the CISD website.

Leadership — Biostatistics & Study Design Program

Philip Lavori, PhD
Leader — Spectrum Biostatistics & Study Design
Phone: (650) 725-6109
Email: email

Mark Hlatky, MD
Co-Leader — Spectrum Biostatistics & Study Design
Phone: (650) 723-6426
Email: email

Program Contact Information

Study design consultation services are provided through the Center for Innovative Study Design (CISD).

To schedule biostatistics/study design consultations click here

To contact the CISD click here.

» Center for Innovative Study Design (CISD) website

» Department of Biomedical Data Science website

Personnel Directory

Philip Lavori, PhD
Professor of Health Research and Policy and, by courtesy, of Statistics
Phone: (650) 725-6109
Email: email

Mark Hlatky, MD
Professor, Health Research & Policy – Health Services Research
Professor, Medicine – Cardiovascular Medicine
Phone: (650) 723-6426
Email: email

Alex McMillan, PhD
Senior Research Scientist
Phone: (650) 725-5352
Email: email
Research design and statistical modeling in medicine and other areas of applied biology. Statistical theory.

Balasubramanian Narasimhan, PhD
Senior Research Scientist
Director, Data Coordinating Center
Phone: (650) 723-6152
Email: email
Statistical computing, Distributed Computing, Random Variate Genertion, Bayesian Sensitivity Analysis

John S. Tamaresis, PhD
Phone: (650) 498-6426
Email: email
Research design and statistical modeling in medicine

Haley Hedlin, PhD
Biostatistician, Quantitative Sciences Unit (QSU)
Email: email
Research design and statistical modeling