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Title: Associate Director, Epidemiology Analytics

12 month contract

Remote - US Based in EST - must be able to come to client site in NJ 1 x quarter

Pay Rate $90/hr - $93/hr

Contracting with this sponsor client offers a strong mix of professional growth, flexibility, and purpose. As a global pharmaceutical leader known for innovation in oncology, cardiovascular medicine, and antibody-drug conjugates, they provide the opportunity to work on cutting-edge projects that make a real impact on patient lives. Competitive pay, flexible schedules, and the chance to collaborate with international teams, gaining valuable global experience. If you are interested in a rewarding contract opportunity to contribute meaningfully while growing professionally, apply now!

RESPONSIBILITIES

+ Provide data management of diverse data (e.g., real-world setting and clinical trial) to set up epidemiologic data sets for various approaches, quantitative epidemiologic data analysis, interpretation of results, visualization of results, and generate manuscripts to disseminate findings

+ Conduct statistical analyses for epidemiological research and safety queries, including but not limited to:

o Descriptive summary and multivariable regression o Exploratory analysis for safety endpoints in clinical trial data

o Setup and analysis of case-control and cohort study designs o Signal detection analysis in spontaneous reports (e.g., FAERS, EVDAS)

o Signal detection/evaluation analysis in RWD

o Data mining (including free-text mining of unstructured data fields) using diverse data sources and methods

o Development of automation platform (e.g., R Shiny App)

o Literature review and meta-analysis

+ Collaborate with cross-functional teams to evaluate and manage adverse events and risks associated with pharmaceutical products. Participate in cross-functional meetings and provide input and guidance as needed. Participate in the preparation and submission of regulatory documents related to drug safety.

+ Maintain and manage project plans to provide deliverables on time.

+ Collaborate with global epidemiology teams to ensure consistency and quality in safety reporting and processes. Maintain compliance with all applicable regulations and guidelines related to pharmacovigilance and drug safety. Stay informed about emerging safety issues and contribute to the development of risk management strategies

+ Mentor and provide guidance to junior team members.

Skills:

+ Experience in epidemiologic methods and data analysis (pharmaceutical industry in safety or associated service provider experience is preferred)

+ Proficiency with programming in R, SAS, or Python for data mining and epidemiologic analysis

+ Strong written, oral and electronic communication skills

+ Excellent leadership skills, with the ability to work effectively in a collaborative team environment

+ The ideal candidate will have a strong background in both biostatistics and epidemiology (or other medical fields)

Education: · Master's degree (with 7+ years of experience) or PhD (with 4+ years of experience) in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology or related field

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.