Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is currently recruiting for an associate director of epidemiology located in Allschwil, Switzerland.
The Associate Director will work under the supervision of more senior members of the department. The primary responsibilities will be to identify research study needs, draft proposals and protocols, review study protocols and statistical analysis plans, and provide suggestions to improve them, and contribute to epidemiology strategy and study conduct across multiple therapeutic areas. In the near term, the primary focus of this role is supporting evidence generation for the pulmonary hypertension therapy area.
- Lead and contribute to the design of observational studies and database analysis, including authoring protocol and analysis plan
- Manage collaborations with external data sources and investigators
- Understand internal data platform use to extract appropriate data sources
- Conduct of analyses, either independently or in collaboration with biostatistics
- Lead and contribute to the synthesis of evidence from literature reviews, observational database analyses and other evidence to inform medical decision-making, including authoring publications and presentations
Additional responsibilities may include but are not limited to the following:
- Participate in various teams to address issues raised by product teams/regulatory agencies
- Provide epidemiological and/or statistical consulting and support to product teams and to the different consortia that Janssen is part of, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature as agreed by the teams
- Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Evaluation and Mitigation Strategies plans / Risk Management Plans
PhD in epidemiology is required
Experience and Skills:
- At least 4years of Epidemiology research experience
- Understanding and the ability to interpret quantitative methods
- Experience with writing protocols in general, and particularly the statistical methods sections of study proposals for observational studies and/or proposal requests
- Experience working with large administrative or medical records databases
- Ability to work in a multi-disciplinary environment
- Strong written and oral communication skills
- Pharmaceutical or Medical Device and Diagnostics industry experience
- Background / experience in rare disease research
- Project management experience
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.
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)