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
Work closely with other scientists, oversight directors, project leads, biostatisticians, and programmers
Lead interactions with clients in the pharmaceutical and medical device industries
Review and finalize project deliverables ensuring validity and reliability of study findings
Oversee budget, deliverables, and project timelines; identify scope expansion and need for amendments
Contribute to thought leadership, such as abstracts and manuscripts as co-author and, when possible, first author
Serve as a consultant to other principal investigators or staff on other projects
Guide and mentor staff across multiple levels
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

PhD in epidemiology or a closely related field, or MSc with at least 5-7 years of relevant 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
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
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
Excellent written and verbal communication skills in English

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short
and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Research Scientist – Epidemiology, Scientific Affairs

Key skills