Description
Senior EpidemiologistA large pharmaceutical company in the South San Francisco Bay Area is urgently looking for a Senior Epidemiologist to join their team. This can be an excellent opportunity for a qualified candidate to join a promising company with an excellent pipeline.
Senior Epidemiologist Duties and Skills
- To work autonomously to maximize the value of a molecule by supporting the development of Patient-Reported Outcome (PRO) strategies during early clinical development and to implement those strategies. The inclusion of PRO measures in trials is critical for creating robust and differentiated product profiles and for providing critical information important for therapeutic decision-making to patients, physicians and payers.
- Lead PRO tool development; implementation into clinical studies; and provide support in developing global PRO assessment strategies for molecules within a therapeutic area.
- Work cross-functionally with Global Development, Global Product Strategy, International Business Teams, Global Health Economics and Affiliates to implement PRO strategies
- Ensure relevant PRO endpoints and study design for registration clinical trial programs meet the needs of global regulatory agencies, reimbursement authorities, physicians and patients
- Assist in identifying PRO instruments and evaluate measurement and psychometric properties of the instruments
- Work with external key opinion leaders to obtain guidance on PRO implementation and emerging methodology
- Contribute to the design, implementation, and management of registration clinical trials containing PROs including the development of the PRO sections of study concept documents, study protocols, statistical analysis plans, clinical study reports and other development documents
- Support the development and/or validation of instruments for PRO as needed
- Adapt and validate instruments for use in different patient populations, including cultural adaptations and translations
- Work with Global Scientific Communications to execute a publication plan that is integrated with overall publication strategy to communicate PRO information to physicians, patients, payers, and policy makers
Education: MS/MPH or higher
This can be a great opportunity for someone to join an excellent pharmaceutical company and progress their career. This is an urgent position and they are trying to bring in people for interviews as soon as possible. If interested please respond with your resume to this post.
To find out more about Real please visit www.realstaffing.com