Senior Director, Vaccine Biostatistics

Why Patients Need You
Pfizer's Worldwide Medical and Safety colleagues play a key role in connecting evidence based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve
As part of the Biostatistics team, you are recognized as a subject matter expert with specialized knowledge and skills in your work. You will design, plan and execute biostatistical components of plans for research and development projects. This will assist in establishing the conditions essential for determining safety, efficacy and marketability of pharmaceutical products.

Role Summary

In this role as Senior Director, Vaccine Biostatistics, you must be proficient in planning, directing, and coordinating a variety of specialized and complex global vaccine development projects. This requires extensive knowledge of the design, analysis, and interpretation of all phases of vaccine clinical trials. You will develop an appropriate statistical framework to answer important clinical and safety questions emerging from various vaccine development programs, as well as the associated regulatory strategies and responses.

You will also roll out new initiatives, develop and refine statistical working models and standards, and assist in strategic planning. This position directs the activities of Pfizer and contract biostatisticians supporting Pfizer's vaccine clinical trials from first-in-humans through post-marketing commitments. This role also requires coordination of statistical approaches across VCRD programs, collaboration with the MDSCA Vaccine organization, as well as knowledge of the design of vaccine effectiveness studies and use of real-world vaccine effectiveness data.

The Senior Director should be a person of vision and should stay current on new developments and technological advancement in statistics.

ROLE RESPONSIBILITIES

• 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.
• Effectively collaborate on high-level cross-functional teams to integrate statistical thinking into developing strategies for vaccine development programs, as well as for proposals, filing documents, and responses to comments and questions from health authorities.
• Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results, exploratory and meta-analysis results, and results from real world effectiveness studies. Provide support for publication activities, scientific presentations and support for product defense.
• Research and develop an appropriate statistical framework to answer important clinical and safety questions emerging from various vaccine development programs and integrate proposals into regulatory strategies and responses.
• Define, review and optimize vaccine statistics business processes, in collaboration with other senior leaders within the unit and, where appropriate, within other Pfizer statistics organizations, to ensure consistency of statistical approaches across studies and submissions, ensure quality, and make best use of resources.
• Provide statistical input and leadership to cross-functional and cross-Pfizer activities/standards/process development. Ensure vaccines-specific and statistics-specific considerations are accounted for.
• Develop effective collaborations with clinicaland submission teams, partner lines, MDSCA, and external regulatory, industry and professional and academic organizations.
• Be accountable for timeliness and quality of study/submission level statistical deliverables on multiple development programs. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
• Take a leadership role in research on statistical methodology and its applications relevant to Pfizer's business needs.

BASIC QUALIFICATIONS

• PhD in statistics or biostatistics with at least 15 years' experience in clinical research and development. Must have substantial experience in vaccine clinical trials, and expertise in statistical epidemiology 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 across multiple vaccine development programs.
• Very broad statistical expertise with applications to clinical trials and observational studies.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Scientific publications
• Ability to perform mathematical and statistical calculations
• Ability to perform complex data analysis

Work Location Assignment:Flexible

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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