PPD Research Scientist/Senior Research Scientist – Data Collection – Peri- and Post Approval Studies (PPAS) in Waltham, Massachusetts
Research Scientist - Data Collection – Peri- and Post Approval Studies
Evidera has been providing epidemiology, data analytics, and outcomes research services to clients in the biopharmaceutical industry for over 19 years. The Peri- and Post Approval Studies team supports pharmaceutical/ biotechnology/ medical device companies in the design and conduct of real-world observational studies throughout the product lifecycle, from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients identify evidence gaps and rapidly build epidemiologic and economic evidence to demonstrate the effectiveness, safety and value of their products. For this role, the focus is on de novo (field) data collection studies such as single and multi-country retrospective chart reviews, surveys, prospective studies, registries and post-market safety studies which are undertaken when existing health databases cannot be used. Increasingly, hybrid studies that invoke the use of both secondary data sources with bespoke data collection methods are deployed to address our clients’ needs.
Data collected in these studies is then used to address key research questions such as:
Burden of disease and identification of unmet needs
Treatment patterns, drug utilization, adherence
The identification and impact of risk factors on disease outcomes
We use epidemiologic methods to build knowledge of the relationships between patient, drug, clinical and disease factors that significantly aids our clients and the patients they serve in understanding health conditions and navigating potential drug-event causal relationships as well as in building stronger evidence-based value messages.
The Research Scientist will take the role of independent principal investigator/consultant of projects and be responsible for overseeing all aspects of project delivery including delegating project management tasks to junior staff. This role will also take scientific responsibility for project completion, strategic consultation, and for use of best methods to address research needs.
Principal Duties and Responsibilities (Essential Functions**):
The Research Scientist in Data Collection will bear scientific responsibility for the design and implementation of de novo data collection studies (retrospective, prospective, and/or cross-sectional).
In particular, the Research Scientist will:
Be scientifically responsible person for design and implementation of selected Non-interventional studies; conceptualize advanced study designs and develop/oversee the development of study protocols, statistical analysis plans and study reports. Responsible for project completion and quality delivery? Delegate coordination tasks to mid-level and junior staff.
Lead interactions with clients in the pharmaceutical and medical device industries.
Review and finalize project deliverables and ensure study findings are valid and reliable.
Have final budget, deliverable and project timeline responsibility; identify scope expansion and need for amendments
Contributes to abstracts and manuscripts as co-author and when possible, first author.
Serve as consultant to other principal investigators or staff on other projects.
Act as a guide and mentor to the staff across Evidera locations.
Lead the growth in your area of responsibility. Direct other "non-billable" activities, e.g. participates to proposals, design conceptual approaches for proposals, supervise junior staff, contribute to business development, identify and pursue business opportunities within Evidera and bring in new projects.
Travel (national and international) is expected.
Participates in client calls and is expected to be able to address questions posed directly to him/her about his/her work
Responsible for scientific consultation and for use of best methods to address research needs.
Contributes to strategic thinking and innovation
Managerial Duties: Possible
Education, Professional Skills & Experience
PhD (epidemiology or closely related field) or MSc with at least 5-7 years relevant experience
Knowledge of drug development process and familiarity with international regulatory requirements.
Broad experience in quantitative methods in health services research, with the focus on design of non-interventional studies and data analysis using observational retrospective and prospective data
Very good understanding of relevant methodology and statistics
Deep understanding of healthcare research principles, knowledge of practical research implementation
Working knowledge of MS Office software; ability to read and understand SAS/STATA output; working knowledge of data analysis software (e.g., SAS, Stata, R) a plus
Demonstrated ability to communicate and document information effectively in written English, including the ability to produce scientific reports, presentations, emails and other written deliverables that are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience.
Strong organizational, time-management, prioritization and decision-making skills necessary to evaluate, plan and accomplish multiple work goals in a timely fashion.
Able to quickly learn and apply new information, skills and procedures.
Proactive and positive approach to tasks and projects, as well as resilience when encountering process, project, budget or client changes that are inherent in the consulting environment.
Strong communication and interpersonal skills including the ability to quickly develop and sustain positive rapport with internal and external contacts in person, over the phone and by email.
Experience presenting ideas to individuals and groups in a formal presentation setting
Delivers a positive internal/external client experience; listens and understand the client's needs, and recommends solutions
Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.
Leverages working relationships with customers and colleagues to quickly develop and sustain positive rapport, build strong connections, cooperation and collaboration in person, over the phone and by email.
Tailors and delivers high-level presentations to diverse audiences using a variety of communication delivery methods (e.g., written, electronic, oral, interpersonal).
Makes independent, critical decisions based on relevant information. Applies solutions based on decisions in a timely manner.
Helps others distinguish relevant from irrelevant information and resolves discrepancies.
Analyzes complex issues and evidence, identify cause-effect relationships, and generate effective solutions.
Receives and learns from feedback.
Desire and ability to guide and coach junior-to mid-to levels of scientific staff.
Experience with design of peri- or post-approval late phase interventional studies is not required but would be considered a plus.
Evidera is a business within in Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.
We offer a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.
Evidera’s Core Competencies:
If you resonate with our core competencies and want to contribute to research and consulting services driven by world-class science and thought leadership, then please submit your application – we’d love to hear from you.
Evidera, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, sexual orientation, gender preference, disability, or status as a qualified individual with a disability or protected veteran.
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