At PPD, you'll have the freedom to try new ideas and the ability to do something truly great. In our environment, innovation is encouraged. That's why the world's leading pharmaceutical and biotechnology companies come to us for discovery and development services. And why PPD is the best choice for you and for your career. Director, Epidemiology Description This is a lead epidemiology position requiring both leadership and management skill sets. The primary purpose is to provide high-level epidemiologic support (conceptual, methodological and statistical) to Registries/Observational Studies and PSPV for pre- and post-approval services; to support the design and conduct of observational studies; and to identify opportunities for, and support of, signal detection, pharmacovigilance, and risk management activities; and to provide strategic insight for the growth of post-approval epidemiologic services.
This position also will provide epidemiologic support to the biostatistics and health outcomes group as they respond to outcomes research and pharmacoeconomic strategies. Operating under minimal supervision, this position will report to the Senior Director of Epidemiology and Pharmacovigilance, and will manage subordinates with the growth of this area. Qualifications
Education and Experience:
- PhD, Dr. PH or ScD in epidemiology
- 5+ five years relevant research experience, including 3 years in a pharmaceutical company or CRO as a pharmacoepidemiologist/epidemiologist (relevant research experience includes research in the areas of pharmacoepidemiology, patient-reported outcomes research or health-related quality of life research)
- Experience in risk management and signal detection is required
Knowledge, Skills and Abilities:
- Understanding of the pharmaceutical industry in general and specific to epidemiology
- Working knowledge of guidance's, and legal and regulatory principles applicable to safety surveillance and pharmacoepidemiology
- Expertise in the design, conduct, analysis, interpretation and communication of observational studies
- Strong epidemiologic analytical skills demonstrated by expertise in epidemiologic analyses using SAS, SPSS and or STATA
- Proficiency with standard desktop and pharmacovigilance computing programs including signal detection and data mining software, and databases (FDA AERS, GRPD) supportive of drug safety research
- Experience developing and executing risk management programs (eg.,RiskMaps)
- Experience using longitudinal national databases (eg. NCHS), claims databases, or electronic medical records (eg. GPRD) for epidemiologic research
- Ability to resourcefully provide estimates of incidence and prevalence of health conditions, disease progression and disease-specific risk factors
- Understanding how to abstract and apply relevant data from large databases (e.g. IMS market research, Managed care claims, National Hospital Discharge Survey, etc.) in support of epidemiologic research
- Understanding of PSURs/PRs and pharmacovigilance plans
- Expertise in exposure estimation
- Expertise in epidemiologic critique and synthesis of epidemiologic research in the literature
- Experience with development and or preparation of post-marketing regulatory reports
- Knowledge of questionnaire and CRF design (including PRO/HRQoL)
- Outstanding communication and negotiation skills
- Ability to prioritize and organize work to meet deadlines while multi-tasking
- Close attention to detail (both visual and mental)
- Demonstrated management skills
- Ability to work in a multi-disciplinary team setting
PPD is an Equal Opportunity Employer
Additional Information
Position Type: Full Time, Employee
Ref Code: 00181  
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