Director Market Access Analytics
il y a 24 heures
We are looking for a Director Market Access Analytics and Real-World Evidence and (MAA & RWE). Responsible for the implementation of MAA & RWE strategies to meet the needs of increasingly evidence driven and cost-conscious HTA agencies around the world. The Director provides functionally robust evidence to inform and complement that generated across Janssen’s R&D clinical development programs.
This role is also responsible for resource planning, project management, leadership skills and managing the relationships with the key Janssen stakeholders.
**ROLE**
Leads and ensure scientific rigor for data generation projects including protocol development, feasibility assessments, planning, management, and publications.
- Production of payer-relevant and HTA-specific evidence in line with agencies’ technical requirements and academic best practices
- Analyses of disease-area relevant endpoints, including surrogate endpoint validation.
- Comparative effectiveness research using (network) meta-analyses and analyses of individual-level patient data from trials and real-world sources (including hybrid studies).
- Providing insights and opportunities for evidence generation with respect to primary (randomized controlled studies and RWE registries) and secondary data sources such as claims data, electronic medical records and surveys.
- Contributes hands-on-experience on innovative statistical methods.
Effectively collaborates with colleagues across different therapeutic areas and functions within Janssen including:
- Aligns with the organizational goals and external requirements to create realizable and relevant evidence generation plans.
- Collaborates closely and builds alliances with members from other departments such as Market Access, Quantitative Sciences, Epidemiology, Medical Affairs and Data Sciences and others to understand key global and regional needs and opportunities.
- Works closely with the Economic Modeling team to leverage synergies with respect to designs and populations.
**QUALIFICATIONS**:
ROLE REQUIREMENTS
- Knowledge of R or SAS or other relevant statistical software.
- Ability to think and act independently and strategically.
- Knowledge of secondary data sources (surveys, claims data, electronic medical records, registries _etc _.).
- Able to manage work into clear and realizable project plans, having identified appropriate resources and setting clear timelines. Managing expectations of all stakeholders involved.
- Strong verbal and written communication skills tailored to cross-functional audiences, for both internal and external communications.
COMPLIANCE AND RISK MANAGEMENT
- Complies with designated SOP’s and mandatory training for the role including pharmacovigilance, Health Care Compliance, and data privacy requirements.
EXPERIENCE
- A postgraduate degree (MSc or PhD) in a relevant discipline (Biostatistics, Data science, Epidemiology, Health Economics) and 7+ years of experience is required.
- Knowledge of Real-World Evidence and experience in evidence generation including dissemination.
- Some track record of developing junior staff in technical skills is an advantage (5+ years).
- Experience of working in a virtual team environment.
- Experience with working with R&D, Biostatistics, Data Sciences, Regulatory Affairs and Compound Development Teams for early as well as late-stage assets in drug development is an advantage.
- Knowledge and applied experience (clinical trials, RWE) in at least one of the following therapeutic areas: Oncology, Pulmonary diseases, Neuroscience, Immunology, Cardiovascular & Metabolism and/or Ophthalmology is preferred.
- Understanding the reimbursement requirements and HTA review process for key international markets is an advantage.
- Strong understanding of regulatory authority processes and guidance’s and drug development is an advantage.
- Proven ability to work effectively in a complex, decentralized, and diverse organization, able to successfully influence in a matrix environment.
This role is based in either Raritan (NJ), Basel (Switzerland) or Beerse (Belgium). Up to 10% travel may be needed.
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