Biostatisticians/Statistical Analysts/Statistical Scientists

A global contract research organisation is looking for a Biostatisticians / Statistical Analysts / Statistical Scientists. The chosen candidate will play a crucial role in the preparation of clinical development plans. This is a hybrid role.

Responsibilities:

Biostatisticians

• Contribute to clinical development plan preparation
• Review of study protocol and preparation of statistical methodologies
• Develop a detailed Data Analysis Plan for assigned projects
• Handle programming of study analysis, review of study results and preparation of statistical methods section for clinical or statistical reports
• Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis, and
• Communicate statistical results to medical writing personnel to ensure accurate interpretation

Statistical Analysts

• Review of analysis plans for appropriate methodologies
• Develop analysis databases
• Handle programming of study analyses and review of study results
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis

Statistical Scientists

• Write statistical programs for use in creating analysis datasets, tables, listings, and figures
• Review analysis plans for appropriate methods
• Program study analyses and review study results
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis

Requirements:

Biostatisticians

• Ph.D. degree in Biostatistics or Statistics
• Prior pharmaceutical clinical trial experience
• Strong experience in SAS® programming or equivalent
• Experience in generation of analysis databases, and analyses for medium to high complexity clinical trial projects, including ISS, ISE, and electronic submissions
• Knowledge of other statistical software
• Knowledge of advanced statistical methods and knowledge of the pharmaceutical industry
• Knowledge of regulatory requirements or guidelines for drug development
• Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
• Experience in generation of analysis databases, and analyses for medium to high complexity clinical trial projects, including ISS, ISE, and electronic submissions
• Bilingual level English and Japanese

Statistical Analysts

• Master’s degree or above
• 2-4 years of SAS® or statistical programming work experience
• Good understanding of data management process
• Clinical trial experience
• Knowledge of clinical database mapping
• Knowledge of statistical methods commonly used in pharmaceutical clinical trials
• Ability to write statistical programs independently for use in creating analysis datasets, tables, listings, and figures
• Bilingual level English and Japanese

Statistical Scientists

• Master’s degree or above in Statistics, Biostatistics, or related field
• Industry working experience with SAS programming, or SAS certificate
• Knowledge of databases and data management processes
• Knowledge of statistical methods commonly used in pharmaceutical clinical trials
• Bilingual level Japanese and English

About the Company:

A global contract research organisation based in the United States. This company provides clinical development services across several sectors.

Keywords:

臨床, 研究, 製薬, 医療, バイオテクノロジー, 統計, 外資系

Job Ref: CXI6YG