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[R&D] / Staff or Manager, Statistician

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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.


Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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