Research Scientist – Epidemiology, Scientific Affairs
Job Description:
- 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
Requirements:
- 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
Benefits:
- 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
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