[R&D] Statistician/統計担当者

Job Summary

• Design, analyze, and interpret clinical trials/post marketing surveillance (PMS) in compliance with relevant regulatory requirements, company standards and best practices

• Provide scientifically rigorous statistical expertise and contributions by working effectively within the clinical triad (clinician, clinical pharmacologist, and statistician)

JOB RESPONSIBILITIES

• 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, and 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 company 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 (i.e., Clinical Data Scientist), Clinical Programming colleagues (i.e., Statistical Data Sciences Lead) – 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 company's data standards that are applicable to statistical outputs, and support processes that require statistical input.

• Communicate and collaborate with global Therapeutic Area (TA) statisticians on assigned projects.

• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.

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

QUALIFICATIONS / SKILLS

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

Technical skills:

• Strong statistical/epidemiological skills with application to clinical trials/PMS

• A broad understanding of drug development