Director Market Access Analytics & Real World Evidence And (MAA & RWE)

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 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, analytics and leadership skills and the relationships with the key Janssen stakeholders.

ROLE
Leads and ensure scientific rigour for data generation projects including protocol development, planning, management, implementation of analyses, interpretation of findings and dissemination/publications.
Job content includes:

• Production of payer-relevant and HTA-specific evidence in line with agencies’ technical requirements and academic best practices

• Extracting and leveraging convincing evidence on treatment patterns, key healthcare resource uses, identification of key populations and sub-groups, along with the corresponding responders.
• Analyses of disease-area relevant endpoints, including surrogate endpoint validation.
• Comparative effectiveness research using (network) meta analyses, matching adjusted methods and analyses of individual-level patient data from trials and real-world sources using range of appropriate methods.
• Support studies in Health Economics, including analytic support for economic models (semi and parametric survival analyses, EQ-5D utility analyses),
• 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 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.
• Works synergisticially with colleagues within team responsible for economic modelling and Health Technology Assessment analyses.
• 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.

ROLE REQUIREMENTS

• Knowledge and familiarity of SAS software or other relevant statistical software such as R, WinBUGS, etc.
• Ability to think and act independently and strategically and take a lead role with regard to methods within projects.
• Strong basis in application of a range of advanced statistical techniques relevant for RWE and MAA and stays abreast of developments in methodology and agency requirements.
• Deep 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 (technical and non-technical), 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.

• 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.
• Track record of overseeing junior staff on projects and helping develop their 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, Infectious Diseases & Vaccines, 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.
• Understanding of regulatory authority processes and guidances 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), Allschwil (Switzerland) or Beerse (Belgium). Up to 10% travel may be needed.