Manager, Bio-Statistician

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募集要項

会社概要

同社は医療用医薬品を研究・開発・製造・販売しています。

業務内容

Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.

Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.

Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.

Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.

Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.

Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.

Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.

Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.

Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.

Communicate and collaborate with global statisticians on assigned projects.

Provide a strong statistical presence in regulatory and professional circles.

Participate in research on statistical methodology and its applications to clinical trials/PMS.

応募条件

Experience:

• At least 3 years of experience in biostatistics for clinical development or post-marketing in drug industry or equivalent

Education/Certification:

• Advanced degree in statistics, biostatistics, or related field

Language:

• Written and oral communication skills in English to effectively communicate with global statisticians

Technical Skills:

• Strong statistical/epidemiological skills with application to clinical trials/PMS
• A broad understanding of drug development
• Knowledge of clinical medicine and regulatory requirements

Behavioral Skills:

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

Consulting skills:

• Capability to provide statistical leadership to cross-functional teams

 

給与

1000 - 1300 万円

勤務地

東京