Manager, Epidemiology And Real-World Data Sciences

hace 3 semanas


Madrid, España Importante Empresa Del Sector A tiempo completo

The Johnson & Johnson MedTech Epidemiology and Real-World Data Science team is recruiting for a Manager, Epidemiology & Real-World Data Science. The primary and preferred locations for this position are Titusville, NJ. Consideration may also be given for this position to be located in New Brunswick, NJ, West Chester PA, Raynham, MA, Cincinnati, OH, or Horsham, PA. Remote work options in the US may be considered on a case-by-case basis and if approved by the Company. The position reports to a Senior Director of MedTech Epidemiology & Real-World Data Sciences within the cross-sector Global Epidemiology Organization and the Office of the Chief Medical Officer.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. The MedTech Epidemiology and Real-World Data Science team is an industry leader in using real world evidence for medical devices and technologies. Our goal is to apply real-world evidence (RWE) as a tool to efficiently address the needs of J&J's MedTech sector and to benefit patients. To do this, we focus in 5 areas: 1) evidence for market access and adoption globally, 2) evaluations of product safety, 3) evidence for regulatory approvals (pre- and post-approval), 4) advancing the use of AI/ML for MedTech, and 5) evidence for business development due diligence and identification of unmet needs.

This position is an exciting opportunity to lead real-world data studies to support the generation of clinical evidence for post-market clinical follow-up activities to meet regulatory requirements, patient safety, health economic and market access needs, and support of clinical, medical, and research and development (R&D) functions. The position requires good judgement in interpreting observational data to support clinical evidence generation.

Key Responsibilities:
You will actively partner with the Health Economics and Market Access (HEMA), Medical Safety, Medical Affairs, Scientific and Clinical Affairs, and R&D. You will co-lead the design and conduct of epidemiologic studies using real world data. A focus is on RWE studies to meet regulatory requirements, particularly European Union Medical Device Regulation (EU-MDR) requirements for proactive surveillance. You will write study protocols and study reports, use a variety of analytical techniques applied to various databases, and strategize regarding research programs. You will leverage epidemiology methods to address emerging safety signals and queries.

Qualifications:
A PhD or MD with at least 2 years of Epidemiology or related research work experience is required, OR a Master's degree in Epidemiology, Health Services Research, Health Outcomes Research, Biostatistics, or other related field with at least 4 years of Epidemiology or related research work experience in health care is required. Experience using a statistical programming language (e.g. SAS, R, SQL, STATA) is required. Experience using healthcare databases, registries, observational study design is required. Experience analyzing and interpreting quantitative data is required. Experience writing epidemiology protocols and study reports is required. Experience in cross-functional collaboration and working in matrix teams is required. Epidemiology or related research work experience in Pharmaceutical or Medical Device and Diagnostics industries is preferred. Strong written and oral communication skills are required. Experience authoring peer reviewed publications (abstracts, posters, and manuscripts) using real world datasets is preferred. This position may require up to 15% of domestic and international travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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