Director, Epidemiology RWE – Immunology, Oncology

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🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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)

🎯 Requirements

• 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

🏖️ Benefits

• 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