Senior Outcomes Research Associate

We are looking for a Senior Outcomes Research Associate to provide scientific leadership within project teams either independently and/or collaboratively with research scientists, in the conceptualization and execution of outcomes research studies. You will be the lead author, co-author, or internal reviewer of client deliverables, including study protocols, final reports, literature reviews, statistical analysis plans, PRO evidence dossiers, poster presentations, and manuscripts.  This role will have substantial client interaction (face-to-face as well as teleconferences) and provide effective and timely status updates, including issues for escalation.  You will be expected to formulate project work plans, ensure project timelines are met within scope and budget, and are aligned with client expectations.  As well as train and mentor junior level staff.  

Responsibilities:

Science

• Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc)
• Understanding of instrument development and validation process
• Able to draft abstracts, posters, oral presentations, and manuscripts
• Able to conceptually fit individual scientific tasks together to determine how the overall scientific goal will be achieved
• Proficient in methodology around ePRO and translations
• When presented with qualitative data, able to design an analysis plan and generate a report fit for client submission
• When reviewing instrument development literature, able to identify gaps between the development and the FDA guidance
• Able to successfully communicate with and advise clients
• Can conceptualize and draft, or lead, a complete proposal based on a client idea or RFP.
• Able to demonstrate advanced scientific leadership and direction to project teams

Project Management:

• Able to identify staff resources required for efficient teams, present the scope of work, and execute the scope by providing direction and feedback to that team
• Managing internal timelines to ensure that deliverables meet external client timelines
• Managing internal budget/staff hours per project not to exceed contracted budget
• Knowledge of project management systems (electronic and paper filing, SOP requirements, finance office practices, IRB needs, etc)
• Ensure project compliance with paper and electronic filing.     Financial & Business Development:

• Lead,  review, and finalize project proposals, including budget
• Modify proposals in response to client requests for changes and scientific insight for client’s strategic needs.
• Independently develop follow-on business with existing clients

OR Operations Support:

• Attends and presents at scientific conferences
• Develops and presents internal scientific trainings
• Participates in staff recruitment efforts
• Conforms to SOPs and other requirements
• Participate in special assignments (e.g. job descriptions, handbook updates, SOP scientific consulting)
• Supervises mid-level scientific staff

Strategy/Consulting:

• Developing client relationships
• Begin to understand pharmaceutical industry and relationship between divisions as they relate to HE/OR groups
• Begin to understand FDA structure and reviewing divisions
• Provide scientifically rigorous deliverables that best help clients meet their objectives
• Work with PI to help identify scientific methods/plans that help clients meet their goals as well as those that will not help clients meet their goals
• Assist PIs in preparing clients for regulatory meetings

Key Performance Metrics:

• Project Management – Number and Dollar volume of projects managed, input from team members
• Proposal Writing Credits in RAP Sheets
• Utilization Rate – Billable work on projects
• Scientific Output – number of key deliverables (proposals, protocols, SAPs, final reports, evidence dossiers, abstracts/posters or podium presentations, manuscripts)

Skills and Experience

• Understanding of health outcomes research principles and familiarity with key aspects of the literature (historical and current)
• Ability to manage or direct large portfolio of projects in terms of dollar volume and number of projects
• Extensive knowledge of practical research implementation (IRB process, data collection and management, knowledge about developing and executing an analysis plan-qualitative and quantitative)
• Understanding of relevant qualitative and quantitative methodology
• Demonstrates ability to work well within diverse project teams
• Excellent communication and scientific writing skills, as demonstrated by peer-reviewed publications, technical reports, or other scholarly work
• Strong analytical and problem-solving skills

Computer skills

• MS Word, PowerPoint, and Excel
• Atlas.ti or advanced qualitative research skills
• Access data entry
• InFormU, EndNot, PubMed/embase, DataFax
• Ability to read and understand SAS output preferred

Education

• Doctorate Degree (e.g. PhD; DrPH; PharmD) in relevant discipline (Psychology, Public Health, biomedical or life sciences); or
• Master’s degree in science discipline, with strong experience in a relevant field.