VP, Global Head of Statistics VCRD

Pfizer is seeking a Vice President, Global Head of Statistics to join our thriving Vaccines Clinical Research Organization in a highly visible leadership and strategic role, contributing to some of our organization’s most transformative programs and directly impacting breakthroughs for patients.

The VP, Global Head of Statistics for Vaccine Clinical Research and Development (VCRD):

• Sets the vision and leadership for providing the highest level of data management, modeling, and statistical advice across the function to senior Vaccines Research and Development (VRD) leadership
• Is accountable to lead the necessary stakeholders to plan, direct and coordinate a large and expanding portfolio of specialized and complex Vaccine Research and Development (VRD) projects spanning phase 1 through phase 4 clinical development
• Must have the broadest knowledge of clinical data management and statistical analysis tools and interpret results from clinical, non-clinical, modelling and simulation, and epidemiologic studies
• Is accountable to develop and roll out new initiatives and lead the VCRD Statistics group in strategic planning
• Leads the activities of Senior Directors directing the statisticians and modelers in VCRD and at Functional Service Providers
• Provides senior management review of protocols and CSRs, and is the senior representative to internal review committees, DMC-related company steering committees, etc.
• Influences cross functional (TA) activities, in a consultative role, and provides the SVP of Clinical Research with more strategic advice as to the present and future direction for the VCRD Statistics group

The VP, Global Head is a visionary leader, current on all new developments and technological advancements both in statistics and modeling areas. This individual is highly respected within the discipline and brings a demonstrated track record of innovation, active in publications, committee activities, presentations and other related activities. Their depth of expertise level will enable the foresight of advising on the evolving capabilities and training needs for the VCRD Statistics group (e.g., consulting and presentation skills).

The VP, Global Head is a respected subject matter expert concerning the FDA, International Regulatory Agencies, and ICH guidelines and regulations applicable for the conduct, analysis and reporting of vaccine clinical trials. This leader provides coaching to Senior Director and Director staff to enable them to engage in and provide quality input at regulatory interactions and with key opinion leaders.

Finally, the Global Head serves as a strong advocate within Pfizer for VCRD Statistics’ involvement taking a prominent role in the vaccine research & development process.

• Provides the highest level of strategic and statistic leadership to VRD leadership and the full vaccine portfolio
• Lead and inspire the VRD statistics organization to provide the highest level of statistical and modeling support. Evaluates the material generated by supervised staff including senior director reports for validity, quality, and effectiveness of presentation and coaches them in preparation for regulatory and Key Opinion Leader interactions.
• Provide senior management statistical review of key documents (protocols, CSRs, regulatory briefings)
• Accountable for timely production and accuracy of all statistical analyses and integrated scientific reports for clinical trial results, exploratory and Meta Analyses, publications activities, scientific presentations and promotional material on assigned studies and regulatory submissions both local and international
• Leadership oversight of representation from VCRD Statistics in communicating statistical issues on studies to clinical, regulatory medical affairs, commercial teams, vaccine and Pfizer senior leadership
• Serves as the company expert and resource on Vaccine statistical and modeling issues, by providing guidance to Clinical, Commercial, and Vaccine and Pfizer senior leadership. Identify, develop, and arrange for training on statistical issues (e.g., event-driven trials).
• Subject matter expert externally regarding developments in new statistical/modeling methodology, and provides training to reports and VCRD. Prepares VCRD Statistics’ staff annual meetings/traveling estimates for input into budget process
• Provides organizational leadership to balance time, quality, and cost requirements
• Strategically set people goals including internal career development and talent management as well as alternative resourcing strategies, where needed.
• Typically manages an organization of between 25 and 40 highly qualified statisticians across multiple Pfizer sites; consisting mainly of permanent staff but supplemented by additional contract resources.
• 15-25% travel may be needed

• Advanced degree in statistics, biostatistics, or related field required. PhD preferred.
• 15+ years of experience in drug development
• 5-10 years of experience in vaccine…