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

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