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 organizations most transformative programs and directly impacting breakthroughs for patients.

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

• 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

QUALIFICATIONS

• 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 development
• At least 5 years of managerial experience in drug development
• Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences
• Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
• A compelling and inspiring leadership style with a sharp scientific mind who combines broad knowledge and understanding of biological systems and statistics. A world-class leader in his/her field.
• Ability to perform sophisticated mathematical and statistical calculations and to perform complex data analysis
• Disaggregates complex problems to facilitate problem solving
• Adept at distinguishing the relevance of information inputs to the decision-making process
• Combines knowledge from multiple sources to generate novel and high impact ideas. Drives conversations to root cause/question asks insightful and probing questions and gets to the next steps effectively.

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.

ORGANIZATIONAL RELATIONSHIPS

• Reports to the Head of Vaccine Clinical Research and Development
• Directly manages Biostatistics team across multiple sites
• Partners with VRD leadership
• Partners with BU Statistics Heads and other Statistics leaders as required

Relocation support available
Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.