Scientist - Psychometrics and Clinical Outcomes Development

OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support our clients in improving health outcomes and patient wellbeing.

We are united as one flexible organization, harnessing the power of the collective to solve complex challenges. Being built from cohesive partnerships across a range of specialist sectors gives us the ability to approach opportunities from fresh perspectives, creating solutions and innovations for market access and medical communications that are informed by the experience and knowledge of the many.

Our global team of experts — many with PhD and PharmD degrees — work strategically alongside our client partners in Medical Affairs, Health Economics and Outcomes Research (HEOR), Market Access, and Commercial teams across a wide range of therapy areas.

You will love this role if you:

• Enjoy harnessing your knowledge of statistics to yield new insights into epidemiology, randomized clinical trials, and endpoint development
• View your statistical and programming talents as a skill and craft through which you are uniquely positioned to generate meaningful scientific evidence
• Enjoy the satisfaction of doing good work more than simply having a job
• Enjoy partnering with clients in advancing evidence-based decision-making
• Are committed to collaboratively working with and supporting your team
• Are comfortable working with remote teams

As part of the OPEN Health Psychometrics and Clinical Outcomes Development (PCOD) team, you’ll be responsible for the following activities:

• Designing, analyzing, and reporting of both interventional and non-interventional studies evaluating clinical outcomes assessments (COAs, including but not limited to, patient-reported outcomes [PROs], wearable devices, and the relationship between these and biomarkers/survival endpoints)
• Developing protocols and analysis plans
• Statistical analysis involving:
• Reporting, drafting and finalizing technical reports, regulatory briefing packages, and manuscripts
• Interacting with federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with occasional interaction with other international regulators
• Building client relationships, which involves communication with both federal grant and pharmaceutical industry funding sponsors

o Linear models
o Generalized linear models
o Linear/generalized linear mixed models
o Latent variable models
o Mixture models

o Survival models (including mixtures and joint models)

What you’ll bring:

• Minimum of a master’s degree in Biostatistics or Psychometrics
• Experience in a comparable industry, ideally from an agency or pharma environment
• Strong attention to detail and superior communication skills (both written and verbal)
• Solid analytical and organizing skills; including the ability to prepare and present relevant summaries of complex materials
• Comfortable in a client-facing role
• Experience mentoring, guiding, and providing hands-on support to junior analysts
• Fluency in at least one primary programming language (R or SAS)
• Proficiency/fluency in at least one secondary programming language (MATLAB, Mplus, and/or FlexMIRT)
• Experience in clinical outcomes assessments (COAs, including, but not limited to PROs)
• Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel)
• Proactive, efficient, and adaptable with the ability to learn quickly
• Experience with submissions to regulatory agencies is desirable

What we offer:

As a global organization, OPEN Health is committed to supporting our employees and their families through a comprehensive benefits program

• Competitive pay, generous paid vacation and holidays, and health insurance programs across all our locations
• Ongoing training and development opportunities which foster and shape your individual career path
• An active and growing commitment to bettering the communities our employees call home through our Corporate Social Responsibility program
• The opportunity to thrive in a global, collaborative environment while working every day to improve health outcomes and patient well-being
• A diverse, inclusive culture that encourages you to bring your whole self to work

KEYWORDS:

(Clinical outcomes research, patient-centred outcomes, COA*, PCO* Statistical analysis, R, SAS, Matlab)