Roche Diagnostics has built a new strategic area – Diagnostics Information Solutions (DIS) - charged with creating a modern portfolio of Clinical Decision Support (CDS) software products that change the way patients are cared for. Our challenge is to bring together complex diagnostic and treatment data from pharmaceuticals, medical devices and IT systems from health care delivery practices and intelligently process and present this data to clinicians, researchers, and caregivers to improve research outcomes and patient care by offering a suite of Clinical Decision Support (CDS) solutions.
As a Principal Quantitative Scientist - Health Economics, part of Data Science & Services (DSS) team at DIS, you are responsible for leading, conceptualizing, planning and executing advanced RWD projects to generate evidence in support of NAVIFY product portfolio as well as clinical tests, diagnostic devices, and services developed and marketed by Centralized and Point of Care Solutions (CPS), Roche Molecular Diagnostics (RMD), Roche Sequencing Solutions (RSS), & Roche Tissue Diagnostics (RTD), leading to better and more efficient patient care. The data you will be working with is varied in type including - but not limited to – clinical patient-level data, supplemented with data such as omics, imaging, digital health, etc. You will lead and collaborate with peers within the function and across the organization to develop and improve existing strategies, CDS and workflow solutions, improve product support strategies, identify evidence gaps and data sources, design and execute studies, implement analyses to support improvement of existing products, and lead discovery and early development of new features or apps to drive the NAVIFY portfolio as well as Diagnostics clinical tests, devices, and services. You will be able to quantify the value of these work products from patient outcomes, business value, as well as from a regulatory perspective.
In this position, you will also ensure that the design, execution, and presentation of evidence and assure that study methodologies are adhering to industry standards and potentially improve and redefine current industry standards. In order to succeed you will leverage and expand knowledge of available healthcare data sources and applicable state-of-the-art analytical methodologies, Hands on experience collaborating with and leading team members who have large scale data processing and visualization, and languages and tools (R, Python, (no-)SQL, Hadoop, Spark, etc.) is required --- colleagues and individuals across the company often ask to work with you as a team lead. In addition, you will rely on your scientific expertise, strategic organizational awareness, strong advanced study design skills, and your ability to interact and influence cross-functional experts such as Life Cycle Leaders, biostatisticians, epidemiologists, product owners and practitioners, to discover novel insights demonstrating impact of various treatment decisions, and uncover key elements leading to best outcomes for patients. You will be recognized across Roche Diagnostics and Pharmaceuticals as a leading expert in the field of Epidemiology and the application of this discipline to RWD studies and CDS product development experience.
- The Principal Quantitative Scientist - Health Economics is responsible for providing data science leadership (expertise for QS) for evidence generation using Real-World Data (RWD), supporting IVD and clinical decision support (CDS) product portfolio at Roche Diagnostics.
- He/she has the primary strategic and operational responsibility for the design, execution, and reporting of RWD studies using a variety of available research and commercial healthcare databases.
- He/she is also responsible for identifying and establishing (participates in the identification and establishment of) collaborations with healthcare institutes expanding sources of available real-world data sources.
- Working closely with clinical science and medical affairs directors across Diagnostics divisions, he/she (assists in) creates, confirms and validates disease & clinical hypotheses for RWD projects supporting commercial, medical and regulatory needs.
- He/She is a key driver and promotes increasing adoption of real-world data to supplement clinical study design and execution, and identifies opportunities where RWD could be the primary evidence generation mechanism to achieve regulatory and reimbursement objectives.
- By leveraging his/her vast experience in evidence generation using real-world data he/she initiates and collaborates on analytics and CDS modules to be deployed on NAVIFY platform. He/She is a key influencer advancing the uses of real-world data for regulatory and reimbursement of IVD and CDS products being developed across Roche diagnostics.
- Develops RWD study protocols and leads analysis projects supporting evidence needs of IVD and CDS product portfolio. Collaborates with internal and external partners (e.g., key opinion leaders, academic institutions, CROs) on the design and implementation of RWD studies.
- Forms and leads strong partnerships with life cycle, medical & scientific affairs, market access teams across Roche diagnostics in understanding RWD analysis needs and priorities, and proposes evidence generation projects addressing these needs.
- Leads RWD analysis projects from start to completion, supporting execution of CDS strategy, and analytical module development.
- Uses RWD to analyze patient pathways and prevalent medical practice to identify opportunities for CDS implementation, and associated value messaging.
- Ensures high quality results from analysis are published as posters, abstracts and manuscripts at a variety of external and internal events and congresses increasing scientific profile and visibility of the organization.
- In close partnership with global regulatory affairs Identifies and leads policy initiatives advancing use of real-world data for regulatory decision making for IVD and CDS products.
- Leads evidence generation projects supporting regulatory submissions, Health Technology Assessments, Market Access & Reimbursement dossiers in collaboration with global cross-functional teams.
- Participates and leads cross industry initiatives involving regulatory and payers to conceptualize, standardize and promote approaches advancing alternative evidence generation mechanisms for IVD and CDS products.
- Using Real-World Data explores and establishes clinical utility of IVD and CDS products in enabling right clinical decisions in a variety of clinical settings. Required to work with the Data Science team to design, implement, interpret, report and publish observational research studies generating evidence to support company products.
- Identifies suitable external academic and industrial partners for conducting RWD studies supporting IVD and CDS portfolio of products. Serves as the data science liaison with the Clinical and Medical groups within Roche and other pharmaceutical companies, and with industry partners to identify and implement collaborative RWD studies, and other projects.
- Reviews publications generated from RWD projects, by company or external collaborators for scientific and medical content. Identifies and provides guidance on opportunities to jointly promote Diagnostic and Pharmaceutical scientific and medical data, in collaboration with Roche and other pharmaceutical companies.
- Contributes in advancing learning and understanding of RWD within Diagnostics Division and serves as Diagnostics expert to develop and/or give presentations at meetings and conferences on the use of Real-World Data in relation to Dia products and medical and clinical areas in which those products are to be used.
- Has the ability to explain the strengths and limitations of Real-World Data – such as national/regional registries, EMRs and other clinical data sources- in the context of designing Real-World Data study designs.
- Maintains knowledge of RWD science methods and their application, and generates awareness and understanding of the same across medical affairs, life cycle teams, market access and regulatory groups.
- Decisions affect success of own area(s) and possibly organization wide success.
- Develops leaders throughout the organization and assures the development of all individuals within the organization.
Who are You?
- Equipped with hands-on experience applying epidemiology in the design and development of RWD studies to generate scientifically valid evidence to make a difference in healthcare.
- Data savvy, creative thinker and problem solver, eager to learn new techniques, identify new data valuable data sources, provide leadership on the integration of those diverse data sources and expand your scientific expertise.
- Reliable team player, strong collaborator with good influential skills and able to establish as a thought partner/leader.
- Excellent communication skills, effective stakeholder management ability, constructive at giving and receiving feedback.
- Strong solution finding, resiliency and a sense of ownership with effective prioritization skills, attention to detail and accuracy.
- Adaptable, embrace and endorse challenges and changes
Minimum Skills and Experience
- Solid understanding and experience of using research and commercial Real-World Data sources, national and regional disease data registries.
- Proven experience in design, implementation and reporting of Real-World Data studies in the Diagnostics/Pharma industry.
- Expert knowledge of regulatory guidelines for Diagnostics/Pharma, proven experience in the use of real-world data in advancing regulatory policy and decisions.
- Expert knowledge of national and international coverage policies and proven experience in the use of real-world data to influence reimbursement and clinical guidelines.
- Strong leadership skills, ability to bring new value to teams by motivating and supervising work of others.
- Excellent communication and collaborations skills (including interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners).
- Good project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors, and external vendors).
- Strategic mindset and can-do attitude.
- Hands on ability to extract, manage, manipulate and use big data sets as part of feasibility studies, able to access raw directly to validate results, generate new hypotheses, investigate new ways of using data in support of RWD analyses.
Background/Experience and Education:
- Masters or Doctoral degree in Epidemiology, Public Health, Health Outcomes Research, or similar areas of academic training is required.
- Clinical credentials (BSN, DVM, MD, Pharm.D.) and/or secondary post-graduate degree (e.g. MS in Biostatistics & Ph.D. in Epidemiology) and/or post-doctoral fellowship experience is highly desirable.
- At least 12+ years of relevant experience including designing and conducting observational studies. At least 5 of these years should have been within the pharmaceutical or diagnostics industry.
- 3+ years of relevant experience in medical affairs or market access functions with proven track record of successfully preparing and submitting evidence dossiers addressing relevant clinical requirement.
- Demonstrated experience in managing regulatory, payer relationships, and KOL management. Solid understanding of healthcare systems, public health and payor systems in a range of countries globally.
- Track record generating RWD studies and evidence to support extended product or medical device claims with the FDA or other regulatory bodies, medical societies, or insurers.
- Knowledge and application of clinical as well as economic metrics to support product or medical device value findings is required.
- Collaborative track record working with business stakeholders and data science team members to generate RWD studies and evidence.
- Successful RWD/E publication history and recent state-of-the-art work.
- Recognized as team leader within the company and across industry with proven experience mentoring Quantitative Scientists as well as Data Scientists with less experience.
- Very good knowledge of English in a business environment.
Roche is an equal opportunity employer.Research & Development, Research & Development > Modelling & Simulation