27 days old

[R&D] / Staff or Manager, Statistician

Pfizer
Tokyo
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**Description of Primary Role & Responsibility**

1. 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.

2. 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.

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

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

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

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

7. 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.

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

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

10. Communicate and collaborate with global statisticians on assigned projects.

11. Provide a strong statistical presence in regulatory and professional circles.

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



**Qualifications, Desired Behavioral and Technical Skills**

1. 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

2. 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

3. Experience

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

4. Education/Certification

Advanced degree in statistics, biostatistics, or related field

5. Language

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



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical



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Posted: 2021-05-26 Expires: 2021-07-03
Sponsored by:
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[R&D] / Staff or Manager, Statistician

Pfizer
Tokyo

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