Clinical Data Standards Scientist

Clinical Data Standards Scientist

12 month Contract

Remote

65 a day

**Skills**:

- Understanding on the healthcare standards especially HL7 FHIR (must have). They are very strict standard and takes too long to learn
- Familiar in programming in python (most preferred), R or SAS
- Clinical data management also a plus

The primary objective pf the Clinical Data Standards Scientist (CDSS) is to explore, evaluate, recommend, and eventually implement data standards and related solutions to deliver efficiencies in integrating the collection of real-world data in clinical studies.Real world data in this context is defined as
- The collection of data from electronic health records.
- The collection of clinical data collected through devices and apps.
- The collection of electronic data from external vendors into clinical data repositories.

The CDSS will work in a multi-faceted environment. The CDSS will be a member of a small standards team focusing on the collection of real word data for clinical research. The CDSS will be a member of the larger Clinical Data Standards (CDS) team. The scopeof CDS covers data collection, data delivery and data analysis. Next to the internal organization, Janssen is a member of industry organizations related to RWD such as PHUSE, CDISC, TransCelerate Biopharma, OHDSI and HL7 Vulcan.

Deliverables:

- **Proof of concept**: The CDSS will technically support the demonstration of feasibility and business value of using RWD in clinical trials by designing, developing, executing, and summarizing proofs of concept with a well-defined scope andobjective.
- **Investment priorities**: The CDSS will support setting the priorities and planning for implementing RWD as a standard solution for Janssen clinical trials in terms of efficiencies for Janssen, investigational sites and patients.
- **Change Management**: The CDSS will evaluate and define the requirements for the larger organization to achieve the efficiencies in RWD collection in Janssen Clinical Studies. The focus will be on the changes required in clinical data managementand clinical data standards processes, systems, and skill sets.
- **Industry Group collaboration**: The RWD clinical data standards team will be working with various industry groups working on RWD. The CDSS will keep track of developments in these industry groups and leverage solutions for Janssen. The CDSSwill also contribute to the various industry working groups with use cases and solutions.
- **Implementation**: Once the decision is taken to invest in standards and solutions for collecting RWD in Jansen Clinical Trials, the CDSS will be working in a cross functional team charged with the RWD implementation objective.

Interfaces Primary/Other:
Primary interfaces:
oInternal: Clinical Data Standards and Clinical Data Management

oExternal: Industry working groups related to RWD

Other Interfaces:
oInternal: Enabling Business Information Solutions and Information Technology

oExternal: CDISC for foundational clinical data standards (CT, CDASH, SDTM, ADaM)

Education and Experience Guidelines:

BS/BA degree

oin life sciences, with project or other experience in data science or informatics

oIn data science or informatics with project or other experience in life sciences

oor data science with life science experience by work experience

Required - Essential

oUnderstanding of HL7 FHIR standards.

oKnowledge of clinical data management principles and practice

oOperational experience in clinical data standards(CDISC:SDTM, CDASH, Controlled terminology)

Required - Desirable

oRave eDC (Medidata Solutions) experience

oETL knowledge or experience

Required - Common

oExperience in prioritizing and managing multiple tasks simultaneously

oOutstanding written and verbalcommunication skills in English