Posted on Apr 6, 2021 by Pfizer
The Director must possess the ability to plan, direct and coordinate a variety of specialized and complex global development 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 help implement new initiatives and assist in strategic planning. The Director directs the activities of contract biostatisticians. This includes resource allocation, directing the scheduling of work assignments, and monitoring project status to assure timely completion of projects. The Director should stay current on new developments and technological advancement in statistics. This person should be highly motivated; should possess excellent written and verbal communication skills; and should be able to effectively collaborate with different functional groups (eg, Statistics, Programming, Data Management).
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 analyses and analyses that synthesize results across studies, support for publication activities, scientific presentations and support for product defense.
Be accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects.
Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
Develop effective collaborations with colleagues within clinical teams, partner lines (such as GPD, PharmSci, SRM, Regulatory, Outcomes Research) and external regulatory, industry and professional and academic organizations.
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 Senior Director of Statistics to plan support for assigned studies and submissions.
Participate in research on statistical methodology and its applications pertinent to Pfizer's business needs.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PhD or MS in statistics, biostatistics or related field with at least 10 years' experience in clinical research and development, including at least 2 years management (direct or matrix) experience. Some experience in vaccine research and development is preferred.
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 and project level.
Strong statistical skills with application to clinical trials.
Effective verbal and written communication skills in collaborating with colleagues and associates both inside and outside the organization.
Providing statistical support and oversight for one or more clinical projects.
Scientific publication review
Set up alerts to get notified of new vacancies.