Beerse, Belgium / Raritan, NJ, US.
We are looking for a Manager Global Market Access Analytics and Real World Evidence and (MAA & RWE). The role includes partnering with Global Market Access and Global Medical Affairs product teams with two key elements: (i) support Janssen’s activities to meet the needs of increasingly evidence-driven and cost-conscious HTA agencies around the world and (ii) to enable access and analyses of high-quality patient-level data across the world. These data and analyses will examine a range of clinical and economic outcomes that will inform, complement, and confirm the evidence generated in our Global R&D clinical development programs.
- Work with Janssen colleagues to understand key global and regional research needs and opportunities. Contribute to Access & Evidence Strategic Reviews and Integrated Evidence Generation Plans (IEGPs) for key products as well as foundational evidence on unmet needs for key disease areas to inform target product profiles (TPPs).
- Provide input and statistical expertise into the concept, design and implementation of non-interventional study protocols and statistical analyses plans to ensure relevant appropriate and scientifically sound methods on study design and analysis are being used, in close collaboration with multi-disciplinary research teams.
- Conduct “hands-on” descriptive and comparative effectiveness research using a variety of sources of patient-level data from prospective and retrospective observational studies, registries, claims- and EMR- databases. Conduct, and post-hoc analysis of clinical trial-data; perform or design (network) meta-analyses of clinical trial results and support and develop cost-effectiveness modelling, across different therapeutic areas.
- Provide insight in the interpretation and discussion of study results
- Communicate analysis results through study reports, internal/external presentations and publications.
- Optimize methodological expertise: develop professional statistical standards by using recognized techniques as well as exploring new developments in statistical methodology and outcomes research, through literature review and attendance/participation at workshops and professional meetings.
- Collaborate closely with the Global market access economic modeling team
- Good understanding of analytical and statistical analyses, clinical trials and epidemiology.
- “Hands-on” experience and knowledge of different RWE secondary data sources.
- Able to organize work into clear and realizable project plans.
- Ability to think and act strategically.
- Strong verbal and written communication/presentation skills.
- Collaboration skills relevant to working across a matrix-based, international organization with multiple stakeholders. Partners in a structured, collaborative, and scientifically rigorous way with external research partners to identify relevant data.
Compliance and Risk Management
- Complies with designated SOP’s and mandatory training for the role including: pharmacovigilence, Health Care Compliance and data privacy requirements.
- A postgraduate degree (MSc or PhD) in a relevant discipline (Biostatistics, Data science, Epidemiology, Health Economics) and 3+ years of experience is required.
- Knowledge of, and “hands-on” experience with RWE sources.
- Experience in evidence generation including dissemination.
- Understanding the reimbursement requirements and HTA review processes for key countries is an advantage. (This includes general requirements as well as specific RWE and meta analyses requirements)
- Proven ability to work effectively in a complex and diverse organization, able to successfully influence and network in a matrix environment.
- Hands-on experience on statistical software (e.g. SAS, R).
- Knowledge of drug development, clinical trials, and clinical practice in a relevant therapeutic area (Cardiovascular &Metabolism, Ophthalmology, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary diseases) is an advantage.
North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Switzerland-Basel-City-Basel
Janssen Pharmaceutica N.V. (7555)
This job is posted by Johnson & Johnson.
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