This position will provide statistical support for clinical Phase I-IV projects in Vaccine Research and Development. The successful candidate will collaborate with study teams working effectively to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports, present results summarizing findings, develop publications of results, contribute to overall clinical development plan as well as provide statistical oversight for Functional Service Provider (FSP) statisticians. The successful candidate would also participate in regulatory submissions and developing responses to regulatory queries. The candidate will directly contribute to Company success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, biomarker strategies and by implementing appropriate statistical methods to facilitate product development.ROLE RESPONSIBILITIES
- Provide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives.
- Be accountable for study and program level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
- Co-ordinate statistical support activities under appropriate business models, e.g., FSPs, including allocation of resources to provide services in line with company priorities, and monitoring progress towards timely completion of services.
- Develop effective collaborations with others within clinical teams and partner lines (such as Development Operations, Safety Risk Management, Regulatory).
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
- Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.
- Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
- Participate in 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, learnings across divisions and locations, and activities for process improvements.
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.
- M.S. degree in statistics, biostatistics or a related field with minimum of 8-year experience in applied statistics; Or Ph.D. degree in statistics, biostatistics or a related field with minimum of 4-year experience.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities.
- Capability to provide statistical leadership within cross-functional teams.
Other Job Details:
- Ph. D. degree in statistics or biostatistics.
- Relevant experience in the design, implementation, analysis and reporting of clinical trials, especially for vaccine development programs, and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.
- Track record of applying advanced statistical skills to clinical trials and submissions.
- Experience of achieving results through outsourcing partners/CROs.
- Knowledge and application of statistical modeling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable.
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
- Eligible for Relocation: YES
- Eligible for Employee Referral Bonus: YES
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.