Research Scientist

Description

• Scientific Accountability: Design and implement de novo data collection studies (retrospective, prospective, and/or cross-sectional), primarily for pregnancy safety studies. Conceptualize advanced study designs, supervise the development of study protocols, study reports, and other scientific deliverables. Review statistical analysis plans. Ensure project completion and quality delivery.
• Collaboration: Work closely with other scientists, oversight directors, project leads, biostatisticians, and programmers.
• Client Engagement: Lead interactions with clients in the pharmaceutical and medical device industries.
• Deliverables: Review and finalize project deliverables ensuring validity and reliability of study findings.
• Project Management: Oversee budget, deliverables, and project timelines; identify scope expansion and need for amendments.
• Thought leadership/Publications: Contribute to thought leadership, such as abstracts and manuscripts as co-author and, when possible, first author.
• Consultation: Serve as a consultant to other principal investigators or staff on other projects.
• Mentorship: Guide and mentor staff across multiple levels.
• Growth: Lead the growth in your area of responsibility. Participate in proposals, design conceptual approaches for proposals, supervise and mentor junior staff, contribute to business development, and identify and pursue business opportunities within Evidera/PPD.
• Travel: National and international travel is expected.
• Management: Possible managerial duties, including actively managing and/or mentoring a team of scientists.
• Participate in client calls and address questions about your work.
• Proactively identify issues and develop strategies for mitigation and/or effective solutions.
• Provide scientific consultation and use the best methods to address research needs.
• Contribute to strategic thinking and innovation.

Qualifications

• Education: PhD in epidemiology or a closely related field, or MSc with at least 5-7 years of relevant experience. Degree in perinatal epidemiology, preferred.
• Experience: Minimum 5+ years of consulting experience (or equivalent) preferred; 3-5 years of management experience preferred. Experience with peri- or post-approval late phase interventional studies and pregnancy/lactation studies is preferred.
• Knowledge: Broad experience in quantitative methods in real-world evidence and health services research, with the focus on design of non-interventional studies and data analysis using observational retrospective and prospective data. Strong understanding of relevant methodology and biostatistics. Knowledge of drug development process and international regulatory requirements.
• Technical Skills: Proficient in MS Office; ability to read and understand SAS/STATA output; working knowledge of data analysis software (e.g., SAS, Stata, R) is a plus.