Location: Santa Clara, CA (local preferred)
Job Category: R&D
Reason: Vacant Position
Reason Detail: Hiring Freeze. Potential to convert to full-time position
Hours Per Week: 40.00
NOTE: this will start remote but strongly prefer someone to be in the Bay Area early 2021
- NO relocation benefits will be offered -
Seeking applicants past experience as an epidemiologist and/or pharmacoepidemiologist who consider themselves to be study design experts (not looking for data scientists). With an MS degree or higher!
Our client has built a new strategic area Diagnostics Information Solutions - charged with creating a modern portfolio of decision support software products 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 within a hospital 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.
Job accountabilities / tasks:
As a Senior Quantitative Scientist (QS), part of Data Science & Services (DSS) team at Client, you are responsible for leading, conceptualizing, planning and executing advanced Real-World Data (RWD) projects to generate evidence in support of NAVIFY product portfolio as well as clinical tests, diagnostic devices, and services developed and marketed by Our client, 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 both a 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. In addition, you will rely on 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 Client Client insights demonstrating impact of various treatment decisions, and uncover key elements leading to best outcomes for patients.
- Senior Quantitative Scientist is responsible for providing data science leadership for evidence generation using RWD, supporting In-Vitro Diagnostics (IVD) and CDS product portfolio at Our client.
- He/she contributes 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.
- He/she is also responsible for 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 science and medical affairs directors across Diagnostics divisions, he/she (assists in) creates, confirms and validates disease & clinical hypotheses for RWD projects supporting commercial, market access, medical and regulatory needs.
- He/She is a key contributor driverand promotes increasing adoption of and advancing the uses of RWD 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 for IVD and CDS products being developed across Our client.
- 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.
- Leads 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.
- 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.
- 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 RWD study designs.
Minimum skills and experience
- At least a Master's Degree in a data science related field (e.g. Epidemiology, Biostatistics) required, PhD preferred.
- Background in biology or medicine, either through education or through professional experience.
- At least 5+ years (9+ years if no PhD) of relevant experience. Industry experience highly desired.
- Solid understanding and experience of using research and commercial RWD sources, national and regional disease data registries. China experience is highly preferred.
- 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
- Language: English, Mandarin highly desired