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Director Biostatistics

Pfizer


Location:
Collegeville, PA
Date:
03/24/2017
Job Code:
1048930-1852
Pfizer
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Job Details

Job Title Director Biostatistics

JobID 1048930-1852

Location: Collegeville, PA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

The Director must possess the ability to plan, direct and coordinate a variety of specialized and complex research projects, must have knowledge of clinical design of experiments, clinical data management and programming tools, and ability to interpret results from clinical studies. The Director should have ability to roll out new initiatives and assists the Senior Director (TA Head) in strategic planning.The Director directs the activities of Pfizer and contract biostatisticians. This includes resource allocation, directing the scheduling of work assignments, and monitoring project status so as to assure timely completion of projects. The Director should be a person of vision, should stay current on new developments and technological advancement in statistics. This person should be highly motivated and should be able to bring different functional groups (e.g., Statistics, Programming, Data Management) together.



*Responsibilities*

Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects.Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations and support to product defense.Be accountable for study level submission level statistical deliverables on assigned projects.Develop effective collaborations with others within clinical teams, partner lines (such as Alliance Partners, DevOps, PharmSci, SRM, Regulatory, Outcomes Research) and external regulatory, industry and professional and academic organizations.Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.Be up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the assigned curriculum.Provide statistical input and leadership to cross-functional activities - collaborate with other statisticians, study managers, alliance partner colleagues - for assigned studies and regulatory submissions.Provide input to the Statistics Head to plan support for assigned studies and submissions.Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.Comply with all statistics and quality processes and Pfizer data standards that are applicable to statistical outputs and support processes that require statistical input.Communicate and collaborate with other project statisticians within the unit to ensure consistency of statistical approaches across studies and alignment with approaches used in phase III regulatory submissions.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 pertinent to the Pfizer business needs.



*Qualifications*

PhD or MS in statistics, biostatistics or related field with at least 10 years' experience in clinical research and development, including at least 4 years Vaccine research and development, and 2 years management experience.Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.Capability to provide statistical leadership to cross-functional teams at the protocol level.Strong statistical skills with application to clinical trials.Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.



*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.





*Director Biostatistics*
*Collegeville, Pennsylvania*
*1048930-1852*


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