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Manager, Digital Medicine Statistics, Early Clinical Development

Employer
Pfizer
Location
Cambridge, Massachusetts
Salary
Competitive
Closing date
Oct 16, 2021

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ROLE SUMMARY

The Manager, Digital Medicine Statistics, Early Clinical Development is 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 and employs 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 with internal 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.


QUALIFICATIONS

Basic Qualifications
  • MSc in Statistics, 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 and three or more years of industrial or similar experience.
  • Technical Skills: 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 ability to multitask.
  • Outstanding communication skills. Ability to explain statistical and modeling concepts to non-experts.
  • Demonstrated ability to work effectively as a part of a team.


Preferred Qualifications
  • PhD in Statistics, 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.
  • Pharmaceutical applications desired; Early clinical (phase I and phase II) and translational experience is an advantage.
  • 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.
  • Knowledge of machine learning algorithms, feature selection and optimization.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel required

Other Job Details

Eligible for Relocation Package

Eligible for Employee Referral Bonus

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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