Roche Diagnostics has built a new strategic area – Roche Information Solutions (RIS) - charged with creating a modern portfolio of decision support software products and generating insights that change the way patients are cared for. Our challenge is to bring together complex diagnostic and treatment data from medical devices and IT systems and intelligently process and present this data to clinicians, researchers, and caregivers to improve research outcomes and patient care offering a suite of Clinical Decision Support (CDS) solutions.
Make a Big Difference
As a Senior Principal Quantitative Scientist, you are responsible for leading, conceptualizing, planning and executing advanced Real-World Data (RWD) projects to generate evidence in support of the CDS portfolio, clinical tests, diagnostic devices, and services developed and marketed by Roche Diagnostics. Contribute to broad product support initiatives and/or studies, lead and deliver on complex projects, and interact with external partners without supervision.
This role can be based either in Santa Clara, CA or in Basel, Switzerland.
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 for instance, the CDS portfolio as well as Diagnostics clinical tests, devices, and services. Quantify the value of these work products from both a patient outcome, business value, as well as from a regulatory perspective. Drive creation of best practices, and proactively share learnings/experience with colleagues both internal and external to the function. Leverage your strategic organizational awareness and systems mindset to implement sustainable, science based practices.
Ensure that the design, execution, and presentation of evidence and study methodologies are adhering to industry standards and potentially improve and redefine current industry standards. 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. In addition, leverage your scientific expertise, organizational awareness, strong advanced study design skills, and your ability to interact and influence cross-functional experts such as biostatisticians, data scientists, and product owners, to discover novel insights demonstrating impact of various treatment decisions, and uncover key elements leading to best outcomes for patients.
Providing RWD leadership for evidence generation using RWD, supporting In-Vitro Diagnostics (IVD) and CDS product portfolio at Roche Diagnostics.
Contributing to 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.
Identifying and establishing (participates in the identification, establishment of and access to) collaborations with healthcare institutes expanding sources of available RWD sources.
Working closely with clinical development, operations, and medical affairs directors across Roche Diagnostics to create, confirm and validate disease & clinical hypotheses for RWD projects supporting commercial, market access, medical and regulatory needs.
Promoting the increased adoption and use of RWD to supplement clinical study design and execution, and identifying opportunities where RWD could be the primary evidence generation mechanism to achieve regulatory and reimbursement objectives for IVD and CDS products being developed across Roche Diagnostics.
Developing RWD study protocols and leading analysis projects supporting evidence needs of IVD and CDS product portfolio. Collaborating with internal and external partners (e.g., key opinion leaders, academic institutions, CROs) on the design and implementation of RWD studies.
Leading RWD analysis projects from start to completion, supporting execution of CDS strategy, analytical module development, and identifying opportunities for CDS implementation, and associated value messaging.
Ensuring 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.
Explaining the strengths and limitations of RWD – such as national/regional registries, EMRs and other clinical data sources- in the context of designing RWD study designs.
Mentoring and coaching more junior colleagues.
Partnering with external key opinions leaders, institutions, academics, etc.
PhD (preferred) OR Master’s Degree in a Quantitative science related field (e.g. Pharmacoepidemiology, Epidemiology, RWD Biostatistics, Pharmacoeconomics, Health Economic and Outcomes Research) and 10+ years of direct related experience.
Background in biology or medicine, either through education or through professional experience.
Solid understanding and experience of using research and commercial RWD sources, national and regional disease data registries.
Proven hands-on experience in generating new hypotheses, extracting/managing big data sets, design, implementation and reporting of RWD studies, in the Diagnostics/Pharma industry.
Expert knowledge of regulatory guidelines for Diagnostics/Pharma.
Expert knowledge of national and international coverage policies and proven experience in the use of RWD to influence reimbursement and clinical guidelines.
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.