TheBiostatistics Manager, Digital Sciences and Translational Imaging Quantitative Sciences, Early Clinical Developmentis responsible for ensuring sound statistical thinking and methods are utilized in the discovery and development of novel digital endpoints; bringing the principles of objective decision-making into the development, validation, and implementation of industry-leading digital health technology programs for incorporation into clinical trials across Pfizer's portfolio; and is an integral member of a matrixed team, which develops andemploys computational and statistical approaches to discover and validate digital endpoints and biomarkers.ROLE RESPONSIBILITIES
- Collaborate with clinical teams and scientists in the design, analysis and reporting of clinical studies incorporating digital health technologies.
- Work with scientists to understand the biology and improve existing or derive new digital endpoints and develop 'fit-for-purpose' statistical models.
- Collaborate with interdisciplinary teams including clinicians, data scientists and data managers to develop, validate and deploy algorithms and analysis pipelines to derive digital endpoints for use in clinical trials.
- Collaborate with other statisticians to ensure rigorous approaches are taken and good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear study objectives.
- Core member of scientific teams responsible for delivering results in a timely and high-quality manner.
- Interact withinternal and external experts to assure sound quantitative approaches are applied to the collection and analysis of a wide variety of data types, including digital health technology data, imaging, and blood-based biomarkers.
- Bring innovative statistical thinking and methods to help drive data-driven drug discovery and development employing modern methods such as machine learning/AI, longitudinal and time series methods, multivariate and functional data analysis approaches, and Bayesian methodologies.
- Use statistical knowledge to prepare both internal and external reports, presentations, manuscripts, and documents for regulatory interaction.
- Ability to collaborate with peers to create business impact.
- MScinStatistics, Biostatistics or in quantitative discipline such as Physics, Applied Mathematics, Bioengineering, Electrical Engineering coupled withhighlevel of statistical expertise.Research experience with mathematical/statistical modeling using complex data andthree or more years of industrialor similarexperience.
- Fluency in R programming
- Strong background in experimental design and statistical analysis including good understanding of inference and probability, competence in contemporary linear and predictive modeling including (longitudinal) mixed models, nonlinear regression, and predictive modeling.
- Genuine interest in biology and pharmaceutical development, with the attitude of self-directed scientist;demonstrated abilityto multitask.
- Outstanding communication skills. Ability to explain statistical and modeling concepts to non-experts.
- Demonstrated ability towork effectively as a part of a team.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- PhDinStatistics, Biostatistics or in quantitative discipline such as Physics, Applied Mathematics, Bioengineering, Electrical Engineering coupled with high level of statistical expertise. Research experience with mathematical/statistical modeling using complex data.
- Technical skills: Programming in Python; Knowledge of SAS and MATLAB is a plus.
- Pharmaceutical applications desired; Early clinical (phase I and phase II) and translational experience is an advantage.
- Knowledge of machine learning algorithms, feature selection and optimization.
- Familiarity with digital health technologies data, such as accelerometry, wearable devices and mobile app data.
- Knowledge of methods of signal processing including electrophysiological data analysis.
- Knowledge of functional data analysis approaches and Bayesian methods is a plus.
Occasional travel required
Relocation support available
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer 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
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