Associate Director, Epidemiology

Arlesheim - Switzerland

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Epidemiology

Job Category:

People Leader

All Job Posting Locations:

Allschwil Basel-Country Switzerland

Job Description:

Job Description

We are currently recruiting for Associate Director Oncology Epidemiology based in Switzerland.

The Associate Director Oncology Epidemiology role is accountable for working independently and in this role will also function under the supervision of more senior members of the department. The Associate Director Oncology Epidemiology is responsible for oversight of various projects and initiatives in areas of epidemiology and real-world evidence research. This includes collaboration and stakeholder engagement with relevant clinical and product related and other RWE related teams leading research projects drafting protocols and statistical analysis plans overseeing the analysis of real-world data (including but not limited to insurance claims data hospital billing data EMRs curated oncology datasets registries) and the dissemination of scientific information through technical reports presentations and publications in peer-reviewed literature.

Primary responsibilities:

Assist with identifying research study needs drafting proposals and protocols and contributing to epidemiology / real-world evidence (RWE) strategy and study conduct across the therapeutic area portfolio.

Work closely in collaboration with colleagues in the Epidemiology group when defining research questions developing epidemiological protocols conducting analyses and interpreting and communicating evidence to internal and external stakeholders.

May conduct fit for purpose database and study feasibility assessments and execute analyses across the product cycle.

Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs.

Provide epidemiological and/or statistical consulting education and support to product teams and disseminate technical information through technical reports presentation and publication in peer-reviewed literature as agreed by the team.

Assist or work independently within and outside of existing electronic databases to:

Assess feasibility of fit-for-purpose RWD; Research natural history of diseases to understand background event rates in the indicated population expected with standard of care
Perform statistical risk assessments; use historical clinical trial data and other data sources to contextualize potential safety issues for new medications; support benefit-risk assessments throughout the product lifecycle; design and conduct post-authorization safety activities including rapid analytics for signal strengthening and formal required/committed evaluation studies as part of Pharmacovigilance and Risk Management Plans.
Participate in various multi-disciplinary matrix teams to address issues raised by product teams/regulatory agencies where real-world data (RWD)/RWE can inform decisions.
Work in cross departmental/sector committees and or other efforts supporting J&J Innovative Medicine.
Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management plans and the development of formal guidance for use of RWE for Regulatory Decision Making.

Qualifications:

PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Masters degree with at least 4 years of hands-on experience is required.

At least 3 years of Epidemiology research experience is required.

Understanding and the ability to apply and interpret quantitative methods is required.

Experience with writing observational study protocols proposals and/or proposal requests particularly the methods sections is required.

Experience working with large administrative or medical records databases is preferred.

A track record of authoring scientific communications (peer-reviewed publications poster or oral presentations at conferences technical reports) is required.

Applied pharmacoepidemiology research is preferred.

Background in epidemiologic material on specific diseases conditions or therapies particularly relating to Oncology therapeutic area is preferred.

Experience working with health authorities is preferred.

Phase III/IV medicine development experience is preferred.

Experience working in a global environment is preferred.

Required Skills:

Preferred Skills:

Advanced Analytics Clinical Operations Cross-Functional Collaboration Data Privacy Standards Developing Others Disease Management Emergency Planning Environmental Health Epidemiology Financial Competence Inclusive Leadership Industry Analysis Leadership Public Health Public Health Surveillance Researching Team Management Vendor Management

Required Experience:

Director