Director, Epidemiology RWE – Immunology, Oncology

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🕒 Julho 18

🏄 California – Remoto

🏄 California – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE • Lead, design, and manage epidemiological, biomarker and/or data science projects • Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries) • Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy • Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed • Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers • Support the effective communication of study/analysis results to support internal and external decisions • Coauthor abstracts and manuscripts for external dissemination of methodologic study results • Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities • Technical Expertise o Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes, • Ability to design studies independently, (ie ability to translate research questions to create study design)

🎯 Requisitos

• PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. • Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development • Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases • A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred • Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment • Ability to manage priorities and performance targets • Experience in leading drug development project for 2+ years for therapeutic area of assignment preferred

🏖️ Benefícios

• company car or car allowance • Health benefits to include Medical, Dental and Vision • Company match 401k • eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • flexible paid time off (PTO) and sick time