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