About Statistical Analysis

Our statisticians objectively evaluate data collected from clinical tests, post-marketing surveillance, and other sources based on biostatistics, and statistically demonstrate the efficacy and safety of products to derive appropriate evaluations. Our statisticians perform comprehensive tasks from the formulation of analysis plans to data analysis (utilizing SAS) and preparation of analysis reports.

  • Our statisticians hold an important position critical to the approval of new drugs and medical devices.
  • Our statisticians are the first to recognize the efficacy and safety of the products they analyze, and they gain a profound sense of accomplishment when the objectives of the clinical trials are achieved.

Flow Workflow

  • Step01

    • Preliminary meeting with clients
    • Statistical consulting (preparing protocols, sample size calculation, PMDA*)
    • Preparation of statistical analysis plans
    • Preparation of mock shells/layout plans

    *Pharmaceuticals and Medical Devices Agency

  • Step02

    • Preparation of analysis datasets (CDISC)
    • Preparation of analysis programs (SAS)
    • Preparation of analysis outputs (tables, listings and figures)
  • Step03

    • QC of analysis datasets and analysis outputs
    • Preparation of analysis reports
  • Our statisticians often handle multiple projects simultaneously, allowing them to gain various experiences.
  • Our statisticians experience analytical work in all areas related to pharmaceutical development, including PK/PD analysis and analysis utilizing RWD (Real-World Data).
  • There are also many projects that involve collaboration with overseas clients and overseas subsidiaries, enabling our statisticians to work in a global environment.

Skill Required Knowledge and Skills

  • Statistical knowledge
  • Programming skills
  • Logical thinking
  • Communication skills

Skill Knowledge and Skills gained on the job

  • Statistics
  • Programming skills
  • Knowledge of CDISC
  • Knowledge of ministerial ordinances (GCP, GPSP, etc.) and ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines

Career Paths Career Path Examples

  • Ms.A

    • Statistical Analysis (3 years)
    • Statistical Analysis Sub-leader (taking the role of leader in individual projects)
  • Mr.B

    • Statistical Analysis (5 years)
    • Statistical Analysis Leader (taking the role of leader in individual projects)
  • Ms.C

    • Statistical Analysis (3 years)
    • Project Management (internal transfer)Statistical
  • Ms.D

    • Analysis (5 years)
    • Statistical Analysis Team Leader (team management within the organization)
  • Mr.E

    • Statistical Analysis (7 years)
    • Statistical Specialist (provide internal and external statistical consulting services)

Data Data

  • Academic background



  • New graduate to Mid-career Ratio



  • Ratio of men to women



  • Age ratio
    of employees





As of March 31, 2023