Pfizer Senior Director, Statistics Lead in La Jolla, California
Position Purpose Provide scientific leadership and technical support for Pfizer clinical and non-clinical projects. This is a science-based position with limited managerial and administrative responsibilities. The primary focus of this position will be to provide statistical leadership in the development and implementation of genomic and other biomarkers applied in clinical oncology development. The applicant is expected to develop effective collaborations and provide statistical leadership with relevant stakeholders including translational oncology leads, precision medicine scientists, clinicians, study statisticians, computational biologists and statistical programmers regarding biomarker strategy and analysis. Activities include assistance with complex and novel study designs and data analyses, and the development of specialized software to support them.
The responsibilities and effort for the position are divided approximately equally between project-specific collaboration, longer-term methodological research to support biomarker development, training, and external activities. The candidate will collaborate with translational biologists and clinicians to expand the strategic use of biomarkers in oncology drug development. These activities include scientific collaborations across academia, industry and regulators. External publications, presentations, and other professional activities are supported.
The successful candidate will:
Develop and implement long-term biomarkers plans and strategies that impact the achievement of Pfizer's submission goals
Provide advice to colleagues across Pfizer on technical and policy issues relating to biomarkers as an internal and external subject-matter expert
Provide and lead in-depth analyses and recommendations to management and senior leaders in complex, ambiguous situations across Pfizer in matters relating to biomarkers.
Influence internal/external regulatory/compliance issues involving biomarkers that have an impact on GPD and other development organizations
Apply technical, line and business knowledge in biomarkers to define the strategic direction of GPD and other development organizations
Increase expertise amongst Pfizer statisticians through dissemination of statistical knowledge, new methodologies and regulatory guidelines
Lead the development and implementation 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,.
Provide external influence through collaborative partnership, scholarship and professional networking with academic, government and industry statisticians
Will be recognized internally and externally as a though leader in biomarker applications
Expand the use of biomarker data in oncology clinical trial designs and analyses
- Directly reports to the Statistical Research and Innovation Group Lead - SRDC, within the Global Biometrics and Data Management organization
Resources Managed (budget and FTEs):
- May supervise the work of contractors, consultants, Pfizer statisticians and programmers
Provide leadership to develop and implement a strategy of biomarkers to advance regulatory submission and approval of assets, especially those for unmet medical needs, across the enterprise
Provide statistical advice on complex statistical problems arising in Pfizer projects, especially those involving biomarker development and their application in clinical trials
Develop, implement, and promote methodologies based on state-of-the-art statistical research and dissemination of the results 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 Translational Biology, Clinical Development, Medical Affairs, Regulatory and other pertinent groups.
Participate actively in discussions towards inclusion of biomarker data in clinical trial designs, key go/no decisions, key regulatory and product defense strategies
Provide a strong presence for Pfizer with regulatory and professional organizations to influence knowledge generation and content of regulatory guidelines and their interpretation in practice.
Develop effective collaborations with relevant non-statistical researchers (such as, Translational Biology, Clinical, Pharmacology, Development Operations, PharmSci, and Safety).
Stay current with research on statistical methodology and its applications pertinent to the Pfizer business needs.
Be up-to-date on training and compliance with all Pfizer SOPs as required based on the assigned curriculum.
"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."
Ph.D. in Statistics or Biostatics or equivalent postgraduate statistical training.
The ideal candidate will have 10 years or more experience in drug development. Experience with oncology clinical trials, genetics data, and other biomarker data will be especially valuable. Candidates with less work experience, or experience in other fields, will also be considered if they have exceptional methodology research credentials and potential.
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.
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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