
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
🔥 0 minutes ago
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10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
• Coordinate end-to-end cross-functional data collection and cleaning activities for clinical studies • Serve as Functional Lead for Clinical Data Science and primary liaison with Project Management, Clinical Monitoring, and other functional groups • Steward clinical data quality and monitor risks through holistic review of clinical and operational data • Identify required data elements and data quality oversight steps supporting study analysis • Communicate, troubleshoot, resolve, and escalate data-related questions and issues • Coordinate cross-functional data cleaning activities to meet quality standards and timelines • Develop clinical data acquisition plans and data flow diagrams • Assess protocol-design and study-parameter risks affecting trial-result credibility and reliability • Develop analytical tools and use platforms or dashboards to detect unreliable data • Perform analytic reviews, identify root causes, and resolve data issues systematically • Monitor and communicate project progress to sponsors and project teams using status reports and tracking metrics • Ensure Clinical Data Sciences activities and milestones meet contractual agreements, SOPs, guidelines, and regulations • Review and maintain budgets and identify out-of-scope activities • Plan, manage, and request Clinical Data Science resources • Coordinate assigned Clinical Data Science teams • Develop and maintain project plans, specifications, and documentation • Maintain ongoing documentation and up-to-date TMF filing • Participate in and present at internal, sponsor, third-party, and investigator meetings • Prepare input for and participate in proposal bid defense meetings and requests for proposals • Prepare documentation for and participate in internal and external audits • Train and mentor new or junior team members • Maintain proficiency in Clinical Data Science systems and processes • Perform other assigned work-related duties
• BA/BS in biological sciences, computer sciences, mathematics, data sciences, or related natural science/health care disciplines; equivalent relevant work experience may substitute • MS degree preferred • Clinical Data Science experience or equivalent combination of education and experience • Twelve years of experience in data management/data science, including four years of project management experience • Experience with Clinical Data Science practices and relational database management software systems • Strong knowledge of the drug development process, risk-based approaches, biometrics procedures, and workflows • Understanding of analytic modeling methods including 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 leadership skills • Knowledge of ALCOA++ data quality principles • Strong experience with protocol interpretation, data collection, and data cleaning specification development • Experience with data analysis, data review, and visualization toolsets including Python, R, Spotfire, and SAS • Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies • Proficiency in MS Windows, Word, Excel, PowerPoint, and email applications • Effective oral and written communication and presentation skills • Good organizational, planning, and time-management skills; ability to multitask under tight deadlines • Ability to adapt to change, work independently, and work as part of a multidisciplinary team • Ability to make effective decisions and manage multiple priorities in a dynamic environment • Minimal travel may be required, up to 25%
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Regular training • Professional meetings/conferences attendance opportunities • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Diverse career paths and employment opportunities
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