Senior Principal Quantitative Scientist - RWD
Company: F. Hoffmann-La Roche Gruppe
Location: Santa Clara
Posted on: April 2, 2021
Senior Principal Quantitative Scientist - RWD 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. 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.-- Responsibilities:
- Providing RWD leadership for evidence generation using RWD,
supporting In-Vitro Diagnostics (IVD) and CDS product portfolio at
- 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
- Identifying and establishing (participates in the
identification, establishment of and access to) collaborations with
healthcare institutes expanding sources of available RWD
- 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
- 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. Who You Are When you join us, you will have
meaningful work developing an innovative technology that saves and
improves lives around the world. As you collaborate with some of
the best in the industry, you will make a huge difference in
disease diagnostics! Our team is collaborative and fast-paced. And,
we offer a competitive salary with a rich benefits package.
- Master's Degree in a Quantitative science related field (e.g.
Pharmacoepidemiology, Epidemiology, RWD Biostatistics,
Pharmacoeconomics, Health Economic and Outcomes Research) and 16
years of direct related experience; or PhD (highly preferred) and
12 years of 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
- 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
- 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 atti Roche is an equal opportunity
employer and strictly prohibits unlawful discrimination based upon
an individual's race, color, religion, gender, sexual orientation,
gender identity/expression, national origin/ancestry, age,
mental/physical disability, medical condition, marital status,
veteran status, or any other characteristic protected by law. If
you have a disability and need an accommodation in connection with
the on-line application process, please email us at
US.Accommodation@roche.com . This website contains information on
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Keywords: F. Hoffmann-La Roche Gruppe, Santa Clara , Senior Principal Quantitative Scientist - RWD, Other , Santa Clara, California
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