The Real-World Evidence (RWE) Leader will be responsible for setting the strategy for real world data efforts for natural history/epidemiology studies, patient centric outcomes research (PCOR), electronic clinical outcomes assessment (eCOA) including eDiaries, digital health endpoints, and support for registries across the Development Portfolio. He/she will be an expert and thought leader in the RWE and have strong relationships with external researchers, collaborators and CROs with access to real world data and will contribute to project delivery by developing the analysis strategy and reporting for real world data. The leader will oversee and ‘own’ data assets and provide strategic insights, operational support and work closely with business partners across Clinical Development, Medical Affairs, Pricing & Reimbursement, Commercial and Regulatory. He/she will report into the Head of Biometrics and RWE.
Job Function and Description
- Develops strategic and operational plans for RWE/PCOR/eCOA and data acquisition/collection including qualitative/quantitative research, literature reviews, measurement, surveys, and endpoint development in support of Spark’s Development and Commercialization objectives.
- Identify, leverage, access/acquire/collect and analyze real world data assets externally to support Spark’s Product Portfolio, understand the Patient Journey and optimize the design of clinical studies (ex. synthetic controls, pragmatic trials).
- Define the evidentiary needs and deliver insights and results at each step of drug development including study design, regulatory submission, label negotiations as well as post-approval support.
- Oversee/’own’ RWE data assets partnering with IT to ensure infrastructure, privacy and security requirements.
- Partner with Study and Asset Teams and Pricing & Reimbursement to set goals, priorities, and deliverables for RWE accounting for the information and data needs at each stage of development including health economics and outcomes research (HEOR) and Market Access needs post approval.
- Serve as a thought partner and collaborate closely with Clinical Development, Medical Affairs, Pricing & Reimbursement including Health Economics Modelers, Market Access, Commercial and Regulatory functions.
- Serve as the primary contact for RWE/PCOR/eCOA efforts within Spark.
- Develop resourcing strategy leveraging CROs;
- 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.
- Collaborate with Pricing & Reimbursement and health economic modelers to provide input on policies, procedures, and other areas of interest as needed to relevant organizations.
- Build/maintain relationships with academic centers, CROs, government and research organizations on RWE/PCOR/eCOA efforts.
- Build out a RWE team as needed to support organizational goals
Education and Experience Requirements
- PhD in Health Outcomes Research, Biostatistics, Epidemiology, Health Policy, Health Economics, Psychometrics or related field
- 15 + years of experience designing and reporting observational studies, clinical outcomes assessments and supporting regulatory submissions/product launch a must.
- Proven success in Pharmaceutical or CRO companies
- Experience leading and managing RWE teams required
- Proven track record in drug development across Phase I-IV supporting RWE for regulatory submission, pricing and reimbursement and product launch and lifecycle management including HTA interactions and reimbursement dossiers.
- 5+ years’ experience programming in statistical analysis systems, such as SAS and R
- Publication track record in peer-reviewed clinical, health outcomes research, and/or methodologic journals.
Key Skills, Abilities, and Competencies
- In-depth knowledge of Real World Evidence, patient centric outcomes research and eCOA related international regulations, guidelines and their applications.
- Expert knowledge and experience of external data sources such as surveys, claims data, electronic medical records, observational trials, digital health data and registries, etc. and the relative strengths and limitations for these data sources
- Strong knowledge of claims and PRO data (particularly in HR-QoL context) and good understanding of HEOR needs to inform burden of illness, cost-effectiveness, and other models preferred.
- Demonstrated knowledge and application of a broad range of outcomes research, statistical, and epidemiological research methods.
- 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.
Internal and External Contacts
Clinical Development, Medical Affairs, Pricing & Reimbursement, Commercial and Regulatory, Biometrics and Real World Evidence departments and Project Teams
Other Job Requirements
Job could include travel 10-20%
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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