Principal Clinical Data Scientist

Description

Principal Clinical Data Scientist
Responsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines.
JOB RESPONSIBILITIES
Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups.
Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis
Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables
Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies. Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.
Design and drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results.
Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies
Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues
Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics
Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
Perform metric collection and data analysis to support continuous process improvement
Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
Plans, manages, and requests Clinical Data Science resources for assigned projects
Coordinates the work of the assigned Clinical Data Science team
Develops and maintains project plans, specifications, and documentation in line with SOP requirements
Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
Actively promote new clinical data science business opportunities aligned with sponsor strategies.
Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
Trains and mentors new or junior team members
Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferences
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)

**Qualifications**:
What we’re looking for

BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience
Clinical Data Science experience or an equivalent combination of education and experience
Experience in Clinical Data Science practices and relational database management software systems
In-depth knowledge of the drug development process and its impact on data quality, in particular riskbased approach, biometrics procedures, workflows.
Sound knowledge of analytic modeling methods such as regression, classification and clustering
Strong project management skills and knowledge of project management methodologies
Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred
Demonstrated staff