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Sr. Manager, Vaccine Quantitative Modeling Statistics

This role can be based at either our Collegeville, PA or Pearl River, NY locations. Relocation will be provided.
ROLE SUMMARY
The Vaccines Non-clinical and Clinical Quantitative Modeling Statistician is responsible for statistical analysis of non-interventional clinical studies (phase 0 studies), epidemiology studies (prospective or large electronic health record database studies) and integrating early biomarker work with existing clinical studies to inform future clinical programs through Phase 1-3 vaccine development programs. Modeling techniques such as Enhanced Quantitative Drug Development, infectious disease transmission models and other statistical models will be utilized to define disease epidemiology, immunologic correlates and predictive risk models. The output will be critical to understanding risk, power calculations for clinical studies and inform decision making at critical stage gates from First in Human (FIH) to planning for post-approval regulatory commitment clinical studies.
The successful candidate will be reporting to the senior director of quantitative modeling lead and working effectively with vaccine clinical teams, vaccine research scientists, internal and external database providers, academic collaborators and CRO teams to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, and write reports and present results summarizing findings. The candidate will directly contribute to the success of vaccine clinical research and development by increasing the strength of study designs, quantitative model development and associated interpretability of results.
ROLE RESPONSIBILITIES
Design and perform analysis of observational databases or prospective studies to provide epidemiology data of diseases and risk factors.
Design and perform analysis of phase 0 clinical studies to support planning and decision making of phase 1-3 clinical trials.
Develop infectious disease transmission models with clinical and epidemiological data.
Develop predictive models with epidemiological and supplemental clinical data to inform clinical trials.
Conduct simulation research with SAS, R or other programming packages.
Conduct data analysis of phase 0 data and epidemiology data for scientific publications.
Design and analyze translational biomarker and epidemiologic studies in partnership with matrix team members including but not limited to clinical research, non-clinical research, medical affairs, commercial and business development.
Develop protocols, write statistical analysis plans, perform statistical analysis, and write reports and present results summarizing findings.
Work collaboratively with Pfizer stakeholders.
Negotiate scientific and operational decisions on data analysis strategy with cross-functional teams and external collaborators.
Contribute to internal and external strategic initiatives to improve efficiency and quality of data analysis.
BASIC QUALIFICATIONS
MSc or PhD in Statistics or biostatistics and demonstration of sufficient mathematical and statistical training.
Relevant drug development experience employing quantitative models.
Four or more years of experience in biostatistics, statistics or related fields in pharmaceutical industry and/or regulatory agencies.
Proficiency in statistical software packages such as SAS, R or S-PLUS.
Experience in designing and implementing infectious disease modeling studies.
Experience in simulation research with SAS, R or other programming language.
Excellent verbal and written communication skills including scientific writing skills and strong interpersonal skills.
Strong work ethic and proven track record of delivering high quality within timelines.
Must possess organizational skills and be able to work independently and in a virtual project team environment.
Innovative in identifying new opportunities and finding new ways to develop knowledge.
Teamwork - must be a strong team player and capable of working in a matrix team environment.
PREFERRED QUALIFICATIONS
Experience of vaccine or infectious disease.
Experience in analysis of large relational databases, especially large electronic health record databases.
PhD in statistics or biostatistics with undergraduate degree in mathematics or mathematical statistics.
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform mathematical and statistical calculations
Ability to perform complex data analysis
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.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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