This role is responsible for leading and ensuring the scientific rigor for data generation projects including dataset feasibility and selection, protocol development, planning, management and publication for specific compounds for Real world evidence, post-hoc trial analyses and meta-analyses. Responsibility across all 6 Therapeutic Areas in Janssen.
Major Duties & Responsibilities
Applies complex statistical analyses such as synthetic external control arm comparisons and surrogate endpoint validations supporting access and launches for key assets.
Ensures scientific integrity with knowledge of and application of a broad range of advanced statistical techniques relevant for RWE and MAA.
Go-to person for advice on key RWE efforts, organizes trainings and mentors other RWE team members as well as pricing and PRO teams and other colleagues.
Self-learning to stay abreast of latest RWE techniques, including testing their application and ensuring in-depth knowledge of agency data requirements for both regulatory and HTA agencies. Include review and sharing of key case study precedents in relevant therapeutic areas.
Required Minimum Education:
A postgraduate degree (e.g., MSc, PhD) in a relevant discipline (Biostatistics, Bioinformatics, Data science, Epidemiology, Health Economics)
Preferred Minimum Education: PhD, PharmD, or MD
Required Years of Related Experience: 12 years of relevant experience
Required Knowledge, Skills and Abilities:
Expert knowledge of trials & the relative strengths and limitations for secondary data sources (surveys, claims data, electronic medical records, registries etc.)
Hands-on knowledge of SAS programming and other significant statistical software (such as R)
Deep expert level experience for multiple techniques of advanced statistical techniques relevant for RWE and MAA.
Recognized thought leader in Real World Evidence (RWE) area of expertise
Strong understanding of regulatory authority processes and guidance’s and drug development
Experience with the drug development process in the pharmaceutical industry is required
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
Ability to present to key RWE stakeholders; Demonstrate exceptional communication and negotiation skills to influence internal stakeholders and / or shape the external environment
Demonstration of an appropriate balance of analytical acumen and R&D acumen, and the ability to influence / negotiate on RWE methodological and technical issues is required
Ability to think and act strategically.
Knowledge of Real-World Evidence and experience in evidence generation including dissemination.
Proven ability to work effectively in a complex, decentralized and diverse organization, able to successfully influence in a matrix environment.
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.
Preferred Knowledge, Skills and Abilities:
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.
Travel%: Up to 15%
Internal Number: 00001H8Y
About Janssen, a Pharmceutical Company of Johnson and Johnson
Company Background & Culture
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.
Who is Janssen?
Are you passionate about crafting a world without disease? Do you have expertise in Health Economics and Market Access? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science.