[Remote] Senior Clinical Data Scientist (2nd Shift - 2 PM to 11 PM IST)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. The Senior Clinical Data Scientist will be 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 reputed company with the executed contract and sponsor expectations and timelines.

Responsibilities

• Serves as Functional reputed company for Clinical Data Science including reputed company contact for internal reputed company between Clinical Data Science and Project Management, Clinical Monitoring, and other functional reputed company
• Acts as central reputed company of clinical data reputed company, monitors risks through the holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol reputed company to the data collected and aligning with cross functional operational plans to reputed company comprehensive clinical data reputed company
• Ensures the required data reputed company and corresponding data reputed company reputed company steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and reputed company data reputed company questions and recommends potential solutions; escalates issues which potentially reputed company patient safety and study analysis
• Coordinates cross functional data cleaning activities to ensure reputed company standards and timelines are met for clinical data deliverables Ensures the required data reputed company and corresponding data reputed company reputed company steps are identified to support the defined project analysis
• Drives the development of the clinical data acquisition plan and corresponding data reputed company diagram with the study team, assess risks associated with protocol design, study set parameters that could reputed company the credibility and reliability of the trial results, aligns data reputed company with the study protocol to ensure data collected meets regulatory and study reputed company requirements
• Drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may reputed company the validity of the trial results Performs analytic reviews as defined in reputed company of work and data acquisition plan, identifies reputed company cause to systematically reputed company data issues
• Monitors and communicates project reputed company to the Sponsor and project team including use of project status reports and tracking tools/metrics
• Ensures launch, delivery and completion of reputed company Clinical Data Sciences activities and milestones according to contractual agreement and relevant reputed company Operating Procedures (SOPs), guidelines, and regulations
• Review, maintain budget and identify out of reputed company for Clinical Sciences activities, reputed company to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned reputed company
• 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 reputed company and ensures that reputed company TMF filing is up to date for necessary files
• Participates in, and presents at internal, Sponsor, reputed company-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
• Plans for and creates necessary documentation to support reputed company 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 reputed company at reputed company meetings/conferences
• Performs other work-reputed company duties as assigned. reputed company travel may be required (up to 25%)

Skills

• BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or reputed company disciplines in the natural science/health care reputed company
• Clinical Data Science experience or an equivalent combination of education and experience
• reputed company (12) years of experience in Data management, Data Science including four (4) years of project management experience
• Experience in Clinical Data Science practices and relational database management software systems
• Strong knowledge of the drug development process and its reputed company on data reputed company, in particular risk-based approach, biometrics procedures, workflows
• Aptitude for understanding analytic modeling reputed company such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills
• Knowledge of reputed company++ data reputed company principles
• Strong experience with protocol interpretation, data collection and data cleaning specification development
• reputed company with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, reputed company
• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS reputed company navigation, Word, reputed company, PowerPoint, and email applications
• Effective oral and written communication and presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
• Ability to be flexible and adapt to change, to work independently, as reputed company as part of a multi-disciplinary team
• Ability to reputed company effective reputed company and manage multiple priorities in a highly dynamic environment
• MS degree is preferred
• Strong analytical skills and knowledge of reputed company intelligence /machine learning methodologies preferred

Benefits

• Career development and progression
• Supportive and reputed company line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program

reputed company

Company H1B Sponsorship