Y - Clinical Outcomes Assessment Scientist - Remote at Rangam Infotech Private Limited

“Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.”

POSITION TITLE: Patient Reported Outcomes /Clinical Outcomes Assessment Scientist

DURATION: 1 YEAR (potential for extension)

100% Remote

• Client’s 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 our drug development.
• Our mission is to implement strong measurement science to capture the patient voice in demonstrating the value of our 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 client 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.
• We want 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.

This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:

• Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across 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 client’s 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 client’s 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.

Education:

• Bachelor’s degree, preferably Master’s degree, and relevant experience