Senior Epidemiologist Job

SENIOR EPIDEMIOLOGIST needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Work cross-functionally with Global Development, Global Product Strategy, International Business Teams, Global Health Economics and Affiliates to implement PRO strategies
- Assist in identifying PRO instruments and evaluate measurement and psychometric properties of the instruments
- Support the development and/or validation of instruments for PRO as needed

WHAT YOU'LL BE DOING:

- 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.
- Ensure relevant PRO endpoints and study design for registration clinical trial programs meet the needs of global regulatory agencies, reimbursement authorities, physicians and patients
- 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
- 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
- Responsible for Vendor management including scope of work development, contract initiation, and project milestones, timelines, deliverables, and budgets

WHAT YOU NEED TO BRING TO THE TABLE:

- Experience and training in public health, pharmacy, health services research, outcomes research, epidemiology or other relevant fields.
- Familiarity and experience with the development and implementation of research strategies (including PRO within registration clinical trials).
- Strong understanding of research methodology and statistics, as well as strong technical writing, communication and presentation skills.
- Possess critical thinking skills, able to set priorities and develop strategies/studies to answer complex research questions
- Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines.
- Ability to work effectively in a cross-functional, project team environment and manage several ongoing projects
- Experience working with key opinion leaders to implement studies as well as on initiatives supporting regulatory filings and/or reimbursement submissions preferred.
- Professional experience in the core therapeutic area of oncology/breast cancer, inflammation, or ophthalmology as well as experience in the biotechnology or pharmaceutical industry preferred

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- MS/MPH or Higher

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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