Senior Director Market Access Analytics and Real-World Evidence (MAA & RWE).

Job content

• Foundational evidence (treatment patterns, disease progression, key healthcare resource use [e.g. hospitalization]), along with identification of key sub-groups and responders.
• Analyses of key endpoints including surrogate endpoint validation
• Comparative effectiveness research using (network) meta analyses and analyses of individual-level patient data from both clinical trials and real-world sources
• Design of studies supporting post-launch evidence generation to confirm treatment benefits.
  
  

• Works closely with Market Access, Commercial and R&D Data Sciences, Epidemiology, Medical Affairs and other colleagues to understand key global and regional research needs and opportunities. Contributes to products’ Integrated Evidence Generation Plans (IEGPs) and Data Sciences plans (foundational evidence) for Disease Area Strongholds.
• Aligns and works closely with other quantitative functions (Quantitative Sciences, Commercial and R&D Data Science, Epidemiology, and regional teams) to drive and implement innovative statistical approaches and increase capabilities (RWE Leadership Team).
• Works closely with the economic modeling team to create synergies with the design and population of cost-effectiveness and budget impact models
• Works closely with Therapy Area Market Access Leaders (TAMALs) to support HTA/payer submission evidence and responses.
  
  

• Knowledge of secondary data sources (surveys, claims data, electronic medical records, registries etc).
• Basic knowledge of SAS programming and other significant statistical software (such as R)
• Ability to think and act strategically.
• Able to manage work into clear and realizable project plans with appropriate resources and timelines.
• Strong verbal and written communication skills tailored to specialist vs. cross-functional audiences for both internal as well as external communications
  
  

• Complies with designated SOP’s and mandatory training for the role including: pharmacovigilence, Health Care Compliance and data privacy requirements.
  
  

• A postgraduate degree (e.g., MSc, PhD) in a relevant discipline (Biostatistics, Bioinformatics, Data science, Epidemiology, Health Economics) and 12+ years of experience is required.
• Knowledge of Real World Evidence and experience in evidence generation including dissemination.
• Track record of managing staff with different experience levels in relation to both technical and leadership skills is required (5+ years).
• Experience of working in a virtual team environment and/or managing direct reports in multiple locations is preferred.
• Knowledge and applied experience with data sciences tools (machine learning, natural language processing, predictive modeling, etc.) is an advantage.
• 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.
• Strong understanding of regulatory authority processes and guidances and drug development is required
• Understanding the reimbursement requirements and HTA review process for key international markets is an advantage.
• Proven ability to work effectively in a complex, decentralized and diverse organization, able to successfully influence in a matrix environment.