Pfizer

[R&D] Statistician/統計担当者

Reposted 5 Days Ago

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Tokyo

Hybrid

Mid level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The Statistician will design and analyze clinical trials, provide statistical expertise, ensure compliance with regulations, and collaborate within clinical teams on statistical deliverables.

Summary Generated by Built In

Job Summary

Design, a nalyze, and i nterpret c linical t rials/ p ost m arketing s urveillance (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 clinica l 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) , C linical 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 S kills :

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

Knowledge of clinical medicine and regulatory requirements

Education/Certification :

Advanced degree in statistics, biostatistics, or related field

Languages :

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

Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical

Top Skills

Clinical Trials

Data Analysis

Statistical Analysis Plans

Statistical Modeling

Statistics

What the Team is Saying

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.