Pfizer Senior Director, Clinical Statistics in Groton, Connecticut
The successful candidate will:
Promote and enhance expertise within the Pfizer statistical community through dissemination of statistical knowledge, new methodologies and regulatory guidelines
Lead the development and championing of techniques based on state-of-the-art statistical research and seek creative solutions through collaborations and interactions with other experts for drug development problems.
Develop effective internal collaborations, and collaborations with the external regulatory, industry, professional and academic organizations.
Provide statistical advice and guidance to Pfizer Management to enable optimal decisions in development and lifecycle support of Pfizer products.
Provide, in partnership with senior statistical leaders, statistical thought-leadership for establishing high-quality, regulatory-compliant quantitative drug development approaches.
Maintain a positive image for Pfizer statistics worldwide through collaborative partnership, scholarship and professional networking .
Provide scientific leadership for statistical advice, and appropriate technical oversight for Pfizer projects.
Actively engage in the development and championing of methodologies based on state-of-the-art statistical research and dissemination of knowledge both internally and externally.
Perform and assist with complex and novel study designs and data analyses and the development of specialized software to support them.
Provide consultation on statistical issues to the Statistics Leadership Team, and Pfizer management in Discovery, Clinical Development, Medical Affairs, Regulatory and other pertinent groups.
Participate actively in discussions towards key go/no decisions, key regulatory and product defense strategies, as well as product lifecycle management to provide high-quality statistical guidance and advice.
Communicate an understanding of the Global Statistics vision and its connection to other parts of the organization.
Provide a strong presence for Pfizer in regulatory and professional circles to influence knowledge generation and content of regulatory guidelines and their interpretation in practice.
Develop effective collaborations with relevant stakeholders (such as, Clinical, Development Operations, PharmSci, and Regulatory and Safety), and promote implementation of quality, productivity and other best practices, including Enhanced Quantitative Drug Development (EQDD) plans.
Be up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the assigned curriculum.
Stay current with research on statistical methodology and its applications pertinent to the Pfizer business needs.
Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learnings across divisions.
Training & Education:
Ph.D. in Statistics or Biostatics or equivalent postgraduate statistical training.
At least 15 years of experience in drug development, with a thorough understanding of the processes associated with clinical and regulatory operations and product defense strategies.
Strong evidence of creative thought-leadership, professional presence, and scholarship through publications and presentations.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
Broad-based understanding of statistical theory and its application is required.
Ability to interact with regulatory agencies on product-specific statistical issues and influence acceptance of novel statistical methods.
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.
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