Alphanumeric is hiring a **Patient Reported Outcomes /Clinical Outcomes Assessment Scientist to work 100% from home based in Canada for one of the biggest Pharma companies in the world.**Patient Centered Outcomes (PCO) team plays an integral role in in the development of integrated evidence plans to ensure that strong PRO/COA strategies support a patient-centric understanding of the drug development. Our client's mission is to implement strong measurement science to capture the patient's voice in demonstrating the value of the products to patients, physicians, payers, and regulators. The team has educational backgrounds across a range of PRO/COA disciplines and experience in pharmaceutical, regulatory, and academic settings. We work in close partnership across functions including clinical development, regulatory affairs, HEOR and patient focused drug development. We are well connected with external initiatives exploring innovative approaches to define, implement and interpret patient centric endpoints in drug development.

The PCO team maintains a sharp focus on the value of patient-centric outcomes across the entire respiratory and immunology portfolio, vaccines and oncology. Our client wants to ensure that each clinical program has a well-characterized, innovative PRO/COA strategy that is defined early in the development lifecycle and has clear plans to develop evidence that supports PRO/COA-related endpoints.

**Please be aware we can only hire people already based in Canada with fully legal and valid documentation to work in Canada. Please apply with your CV in English.**Conditions

Working hours: Monday to Friday ideally 8AM - 5PM EST but flexible, 37.5 Hours/Wee
Contract: 1 year with potential for extension
Type of Employment: Contractor (need to be registered in the CRA)
Type of Work: 100% remote from wherever you want in Canada
Location of the office: Ontario
Salary: from 250 CAD$/hour depending on experience

ResponsibilitiesThis role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:
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Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across the client's portfolio
Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies
Work cross-functionally (e.g., clinical operations, biostats teams) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analyzed appropriately in clinical trials (and are accurately described in statistical analysis plans, study reports and publications)
Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings to support patient-centric endpoint strategies
Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts) which present PRO-related results from clinical trials and/or PRO development and validation studies
Maintain awareness of scientific and regulatory changes across specialty and primary care drug development programs
Pursue ongoing learning to understand and adopt evolving methodologies and guidelines (including those from regulatory authorities) and communicate findings to cross functional groups as needed.

Mandatory Requirements

Bachelor’s degree, preferably Master’s degree in relevant Pharma areas.
Relevant experience in similar roles

Patient Reported Outcomes /Clinical Outcomes Assessment Scientist - Remote (based in Canada)