Senior Clinical Data Scientist – 2nd Shift, 2 PM to 11 PM IST

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee comprehensive cross-functional data collection and cleaning processes for clinical studies.

• Act as the Functional Lead for Clinical Data Science, serving as the main point of contact with Project Management, Clinical Monitoring, and other functional teams.

• Ensure the quality of clinical data and monitor risks through a thorough review of both clinical and operational data.

• Identify necessary data elements and implement data quality oversight measures to support study analysis.

• Address, troubleshoot, resolve, and escalate any data-related inquiries and issues.

• Facilitate cross-functional data cleaning efforts to adhere to quality standards and timelines.

• Create clinical data acquisition strategies and data flow diagrams.

• Evaluate protocol design and study parameter risks that may impact the credibility and reliability of trial results.

• Develop analytical tools and utilize platforms or dashboards to identify unreliable data.

• Conduct analytic reviews, pinpoint root causes, and systematically resolve data issues.

• Track and communicate project progress to sponsors and project teams through status reports and performance metrics.

• Ensure that Clinical Data Sciences activities and milestones align with contractual obligations, SOPs, guidelines, and regulations.

• Review and manage budgets while identifying activities that fall outside the agreed scope.

• Plan, oversee, and request resources for Clinical Data Science activities.

• Coordinate the activities of assigned Clinical Data Science teams.

• Develop and maintain project plans, specifications, and documentation.

• Keep ongoing documentation current and maintain up-to-date TMF filing.

• Participate in and present at meetings involving internal teams, sponsors, third parties, and investigators.

• Prepare contributions for and engage in proposal bid defense meetings and requests for proposals.

• Prepare documentation for and partake in both internal and external audits.

• Train and mentor new or junior team members.

• Maintain expertise in Clinical Data Science systems and processes.

• Carry out other assigned work-related responsibilities.

⛳️ Requirements

• BA/BS in biological sciences, computer sciences, mathematics, data sciences, or related natural science/healthcare fields; relevant work experience may be considered as a substitute.

• MS degree is preferred.

• Experience in Clinical Data Science or a comparable combination of education and experience.

• A minimum of twelve years of experience in data management/data science, with at least four years in project management roles.

• Familiarity with Clinical Data Science practices and relational database management software systems.

• Profound understanding of the drug development process, risk-based approaches, biometrics procedures, and workflows.

• Knowledge of analytic modeling techniques, including regression, classification, and clustering.

• Strong project management capabilities and familiarity with project management methodologies.

• Robust analytical skills and knowledge of artificial intelligence/machine learning methodologies are preferred.

• Proven leadership skills.

• Familiarity with ALCOA++ data quality principles.

• Extensive experience with protocol interpretation, data collection, and the development of data cleaning specifications.

• Proficient in data analysis, data review, and visualization tools such as Python, R, Spotfire, and SAS.

• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies.

• Proficient in MS Windows, Word, Excel, PowerPoint, and email applications.

• Strong oral and written communication skills as well as presentation abilities.

• Excellent organizational, planning, and time-management skills; capable of multitasking under tight deadlines.

• Ability to adapt to change, work independently, and collaborate within a multidisciplinary team.

• Capable of making effective decisions and managing multiple priorities in a dynamic setting.

• Minimal travel may be required, up to 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Regular training sessions.

• Opportunities to attend professional meetings and conferences.

• Access to extensive resources including emerging technologies, data, science, and knowledge sharing.

• Varied career paths and employment opportunities.