Genentech: Principal/Senior Principal Outcomes Research

Genentech
Posted

Post Expires

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Researcher / analyst

  • https://www.gene.com/careers/detail/201909-127977/Principal-Senior-Principal-Outcomes-Research

The Position

We are looking for a Senior PCOR Scientist responsible for providing quantitative measurement expertise for the development and execution of patient-centered fit-for purpose measurement strategies throughout the drug development lifecycle. This includes developing, implementing, interpreting and disseminating analytics to inform the validity of instruments/endpoints for inclusion in evidence dossiers directed towards regulators and payers. Proficiency in statistical programing (SAS, R), psychometric theory and analysis methodology, as well asclinical trial statistics is expected. Familiarity with CDISC data standards and handling/analyzing clinical trial data strongly preferred. Accountabilities typically extend to representing PCOR or the wider Biometrics function across global development teams or other cross-functional expert groups both within the Genentech/Roche Organization and with external collaborations.

Accountabilities

PCOR Scientists are Members of the Genentech, a member of the Roche group/Roche Data Scientist Family that are recognized for:

  • Serve as a subject matter expert in psychometrics/clinimetrics.

  • Design, conduct and/or supervise functional service provider(s) conduct of psychometric or statistical analyses for COA data (traditional survey-like instruments and novel wearables).

  • Lead in design and evaluation of emerging technology with potential use in research activities (e.g. pREDi, PHC DHP) to ensure relevance as a patient-centered measurement tool.

  • Supervises/consults on all aspects of COA data formatting in clinical study or registries to enable analyses from different sources.

  • Evaluate patient-relevant evidence including performance of measurement to support decision making.

  • Serve as SME for developing solutions to complex scientific/technical problems related to measurement tools (including technologies) and clinical trial delivery.

  • Provide expert advice or supervision in implementation of novel practices: experimental design, data capture and analysis for non-clinical projects (e.g. Registries, observational studies, FAIR Data initiatives); Lead establishment of best practices and innovation within the field.

Qualifications & Competencies

  • Advanced Degree in Psychometrics, Psychology, Education, Statistics, or similar areas OR substantial expertise in relevant/target areas. Experience with Classical and Modern Test Theory, including Item Response Theory and its applications.

  • Typically has a total of 8+ years direct/indirect biopharmaceutical industry experience or equivalent combination of education and experience.

  • Successful demonstration of quantitative research conduct: surveys, endpoint development, instrument development and validation, COA execution, clinical trial design.

  • Good knowledge of English in a business environment. 

  • Good understanding of regulatory guidelines in a pharmaceutical research setting.

  • Good project management skills: ability to manage scope, delegation, timelines, vendor performance.

  • Understands and respects cultural differences when interacting with colleagues globally.

  • Results driven: interest and ability to learn new things, is solution oriented.

  • Effective in mentoring

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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More Information

Posted

Post Expires

Type

Researcher / analyst

South%20San%20Francisco%2C%20United%20States

South San Francisco , United States