Principal Quantitative Scientist (Diagnostic Devices) Full-time

Principal Quantitative Scientist

At Roche, you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop, and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As a 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, leading to better and more efficient patient care. You will contribute to broad product support initiatives and/or studies, lead and deliver on complex projects, and interact with external partners without supervision.

The data you will be working with are 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 products from both a patient outcome and business value, as well as from a regulatory perspective. You will drive the creation of best practices and share learnings/experience with colleagues both internal and external to the function to shape the use of RWD and implement sustainable, science-based practices in Diagnostics.

The Opportunity:

In this position, you will also ensure that the design, execution, and presentation of evidence adhere to the highest scientific standards. To succeed, you will leverage your expertise and expand your knowledge of available healthcare data sources and applicable state-of-the-art methodologies. Hands-on experience with large-scale processing and visualization of RWD through various languages and tools (e.g. R, Python, (no-)SQL, Spark, etc.) is required. In addition, you will rely on your scientific expertise and your ability to interact and influence cross-functional experts such as clinical biostatisticians, data scientists, and product owners to discover novel insights demonstrating the impact of various treatment decisions and uncover key elements leading to the best outcomes for patients.

This role is hybrid in our Indianapolis Roche location (must be 3 days on-site a week).

Responsibilities include:

• Provide RWD leadership for evidence generation using RWD, supporting In-Vitro Diagnostics (IVD) and CDS product portfolio at Roche Diagnostics.
• Drive 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.
• Identify and establish collaborations with healthcare institutes expanding sources of available RWD sources.
• Work closely with product leads, clinical development, clinical 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.
• Promote the increased adoption and use of RWD to supplement clinical study design and execution, and identify 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.
• Develop RWD study protocols and lead analysis projects supporting evidence needs of IVD and CDS product portfolio. Collaborate with internal and external partners (e.g., key opinion leaders, academic institutions, CROs) on the design and implementation of RWD studies.
• Lead RWD analysis projects from start to completion.
• Ensure high-quality results from studies 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.
• Explain 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.
• Mentor more junior colleagues and act as an influential subject matter expert to your team members and the businesses you support.
• Stay committed to offering innovation, finding opportunities to enhance ways of working (including processes, methods, technology, etc.), and sharing learnings pro-actively with peers.
• Use and continue to foster strong working relationships with global colleagues and customers, and build a strong network in order to jointly explore vendor relationships, data assets, analytical methodologies, and toolsets.
• Partner with external key opinion leaders, institutions, academics, etc.

Who You Are (Required):

• You hold a PhD (preferred) OR Master's Degree in a Quantitative science related field (e.g. Pharmacoepidemiology, Epidemiology, RWD Biostatistics, Pharmacoeconomics, Health Economics and Outcomes Research).
• And 7+ years of direct related (industry, consulting, or other relevant) experience required.
• Solid expertise in epidemiology and causal inference methodologies is required.
• Strong programming experience with R, Python, and/or other quantitative software.
• Strong experience in using research and commercial RWD sources, national and regional disease data registries.

Additional Skills:

• Proven hands-on experience in generating new hypotheses, extracting/managing big data sets, designing, implementing, and reporting of RWD studies, in the Diagnostics/Pharma industry.
• Understanding of regulatory guidelines for Diagnostics/Pharma.
• Expertise in national and international coverage policies and proven experience in the use of RWD to influence reimbursement and clinical guidelines.
• Excellent communication and collaboration 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).
• Strong 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.
• Professional working proficiency in English is required.

You are local to Indianapolis, IN. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of Indianapolis, IN is between $124,500 and $231,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.