Research Associate III - Real-World Science, Epidemiology & Scientific Affairs – Pregnancy Studies

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The Real-World Science, Epidemiology and Scientific Affairs team focuses on generating real-world evidence and supports biopharmaceutical companies throughout the product lifecycle, from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries generate real-world evidence to demonstrate and support the value of their products. Through the generation of real-world data via the design, implementation, and analyses of observational/non-interventional studies, we may provide key information such as: 

• Incidence and prevalence of diseases and co-morbidities, and their risk factors
• Burden of disease, unmet needs
• Treatment patterns and drug utilization
• Healthcare resource utilization
• Overall safety, incidence of adverse events of special interest
• Effectiveness and comparative effectiveness data
• Pregnancy safety studies (e.g., pregnancy exposure registries, descriptive pregnancy safety studies)

This position will focus on supporting pregnancy safety studies.

Position Overview:

The Research Associate III drafts project deliverables, interacts with clients, and contributes to strategic thinking under the direction of senior staff. The Research Associate III also supports scientific coordination and project management.

Essential Duties and Responsibilities (other duties may be assigned):

The Research Associate III will bear scientific responsibility for the development of scientific deliverables (e.g., protocols, reports) that accurately summarize the study design of de novo data collection projects (retrospective, prospective, and/or cross-sectional) under oversight of more senior staff. The primary focus of this position will be to support pregnancy studies (e.g., pregnancy registries, descriptive pregnancy safety studies).

In particular, the Research Associate III will:

• Participate in scientific guidance/consultation on scientific methodological and operational considerations of project design and conduct
• Lead on or oversee development of project deliverables (e.g., protocols, case report forms (electronic or paper), survey questions, reports) for senior review.
• Interact directly with project sponsors, physician experts, and clinical sites, if appropriate and under the guidance of senior staff
• Assist the responsible scientist with monitoring project budget spend and managing timelines for scientific tasks/deliverables. 
• Participate in the development of abstracts and manuscripts
• Contribute to the growth of Prospective Real-World Studies through business development activities, including support of proposal development, participation in the sales cycle, and, when appropriate, presentations 
• Support other organizational activities as needed (e.g., supervise and/or mentor junior staff, closely collaborate with other project stakeholders such as clinical operations, data management, biostatistics, and data analysts; contribute to development of training materials and process improvements)
• Travel (national and international travel) may be expected

Consulting Expectations:

• Participates in client calls and is expected to be able to address questions posed directly to him/her about his/her work
• Contributes to strategic thinking under the direction of senior staff.

Education, Professional Skills & Experience:

• PhD (epidemiology or closely related field) or MSc with 1-5 years of relevant experience; advanced degree in perinatal epidemiology or equivalent training and/or experience in pregnancy highly desirable 
• Experience with de novo data collection (field) projects (non-interventional designs in particular) is highly desirable
• Good understanding of epidemiologic methodology
• Previous experience in consultancy and/or CRO environment highly desirable
• Working knowledge of MS Office software; working knowledge of data analysis software (e.g., SAS, Stata, R) a plus
• Experience with design of peri- or post-approval late phase interventional projects is not required but would be considered a plus

Personal Skills & Competencies:

• Demonstrated ability to communicate and document information effectively in written English, including the ability to produce scientific reports, presentations, emails