Statistics Services

The George Clinical statistics team has extensive experience in the design and analysis of clinical trials, including adaptive designs. Our statistics team are familiar with a wide range of therapeutic areas.

Statistics Services

The George Clinical statistics department operates globally to provide data and expertise that will enable faster, more informed decisions with reliable and flexible service. The biostatistics team has extensive experience in the design and analysis of clinical trials in a wide range of therapeutic areas.

Solutions are tailored to customers’ requirements include Phase I – IV Clinical Trials, Late Phase / Real World studies, Regulatory Submissions, as well as complex surveys, longitudinal studies, and risk score development. We also execute innovative statistical research programs aimed at addressing methodological problems relevant to our research.

 

Our Solutions and Expert Staff

We support clinical trials and other research projects from conception to publication. All the analyses use up-to-date and validated software (e.g. SAS and Stata for statistical analyses, PASS for sample size calculations, and nQuery) and are performed to ICH GCP standards with emphasis on validation, traceability and reproducibility.

George Clinical’s statistics experts analyze and design clinical trials across a broad range of therapeutic areas, including, but not limited to: Oncology, Cardiology, Neurology, Respiratory, Nephrology, Endocrinology, Pain Control, Infectious Diseases, Critical Care, Substance Abuse and a diversity of Medical Devices.

To see the breadth of our networks in each therapeutic area, please click on the below links:

Solutions tailored to customers’ requirements include Phase I – IV Clinical Trials, Late Phase / Real World studies, Regulatory Submissions, as well as complex surveys, longitudinal studies, and risk score development. We also execute innovative statistical research programs aimed at addressing methodological problems relevant to our research.

 

George Clinical biostatistics department’s key outputs include:

  • Study design and protocol review
  • Sample size and power calculations
  • Randomization
  • Statistical analysis plan
  • Modeling and simulation
  • Adaptive trial design
  • Biostatistics consulting services
  • Feasibility analysis
  • Biomarkers and early clinical decisions
  • CDISC (SDTM and ADaM)
  • Data Safety Monitoring Board (DSMB) support
  • Interim analyses
  • Statistical analysis/TLF production 
  • Independent/unblinded analyses and support
  • CSR input
  • Narratives Programming
  • Patient profiles
  • Data conversion and integration
  • Submission strategy, planning, and analyses
  • Expert testimony, regulatory support/meetings
  • Ad hoc and conference Support
  • Post-marketing manuscript support
  • Pharmacoeconomics
  • Competitive analysis
  • Late phase solutions
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    Statistics Services Scientific Leadership

    Daniel (Yanhe) Wang, MD, PhD

    • Head of Biostatistics

    Daniel (Yanhe) Wang, MD, PhD Head of Biostatistics, George Clinical Daniel is the Head of Biostatistics at George Clinical, MD and PhD of Fudan University, and he was an associate researcher at the Chinese CDC. He has nine publications and more than fifteen years’ work experience in biostatistics. Daniel has experience in leading, reviewing and performing oversight on hundreds of clinical trials from Phase I–IV in the therapeutic areas of oncology, immunology, cardiology, respiratory, neurology, endocrinology, nephrology, infectious diseases and medical devices. He also has experience as a physician and statistics method exploration. He is very familiar with every step of the clinical development process, from the study design to the end of the study and final statistical output/study report, as well as the SOPs in CRO, ICH/GCP, and the guidelines such as RECIST and CTCAE.  

    Stephen Jan is Head of the Health Economics and Process Evaluation Program at the George Institute for Global Health and Professor, Faculty of Medicine, UNSW Sydney.

    He is an Honorary Professor at the University of Sydney, a Director of the Sax Institute and an Associate at both the Menzies Centre for Health Policy and the Poche Centre for Indigenous Health. He is a current NHMRC Principal Research Fellow and has previously held posts at the London School of Hygiene and Tropical Medicine and the Centre for Health Economics Research and Evaluation (CHERE) in Sydney. Stephen has over 20 years of experience in health economics, has published over 200 scientific articles and authored two textbooks in health economics.

    He has worked closely with various governments of different levels, both in Australia (Commonwealth and State) and overseas, with international agencies such as the WHO and industry. His areas of expertise are economic evaluation, health financing, health sector priority setting, Indigenous and global health issues and the economics of chronic disease.

     

     

    Laurent is a senior biostatistician with 20 years of experience in health research. He is Director of the Statistics Division at the George Institute for Global Health and Associate Professor, Faculty of Medicine, UNSW Sydney.

    He is responsible for providing statistical services to the George Institute and its collaborators in Australia and globally. He holds a Master of Science in Statistics and Computer Science and a Master of Research in Public Health (Biostatistics). He is an accredited statistician by the Statistical Society of Australia (AStat).

     

     

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