Principal Clinical Programmer (DM SAS)
Location: Hyderabad, India
Work Mode: Hybrid
Department: Clinical Data Management & Clinical Programming
Job Overview
We are seeking an experienced Principal Clinical Programmer (DM SAS) to lead and support clinical programming activities across multiple clinical studies and programs. This role is responsible for designing, developing, validating, and maintaining clinical data management solutions, SAS programs, Electronic Data Capture (EDC) systems, and reporting tools that support clinical research operations.
The successful candidate will act as a senior technical subject matter expert, providing leadership, project oversight, technical guidance, and programming support while ensuring high-quality deliverables across clinical trials and data management projects.
Key Responsibilities
Clinical Programming and SAS Development
Design, develop, validate, and maintain SAS programs and clinical programming solutions.
Create and maintain SAS listings, custom reports, macros, and data processing programs.
Develop programming specifications and validation documentation.
Support clinical data collection, processing, reporting, and analysis activities.
Ensure all programming deliverables meet quality standards and project timelines.
Electronic Data Capture (EDC) and Database Management
Support the design, development, and maintenance of EDC systems and study databases.
Configure and validate:
Annotated Case Report Forms (CRFs)
Database Builds
Coding Configurations
Edit Check Procedures
Data Imports and Exports
Custom Reports
Support clinical data acquisition and integration processes.
Clinical Data Management Support
Provide technical expertise to Clinical Data Management and Clinical Programming teams.
Support study build activities, data mapping, data validation, and reporting requirements.
Ensure efficient management of clinical data workflows and data quality processes.
Assist with database updates, system enhancements, and application administration activities.
Project Leadership and Oversight
Lead clinical programming activities across multiple concurrent studies.
Manage project timelines, resources, priorities, and deliverables.
Monitor project scope and identify potential risks or resource constraints.
Provide input on study budgets and support change order management processes.
Ensure timely escalation of project issues impacting timelines, quality, or budget.
Technical Subject Matter Expertise
Serve as a subject matter expert for:
SAS Programming
Medidata Rave
Oracle Inform
Oracle RDC
Clinical Reporting Tools
Data Management Systems
Provide second-level technical support for system issues and application performance concerns.
Support system integrations, application updates, and user acceptance testing activities.
Quality Assurance and Compliance
Perform senior-level review of study and program deliverables.
Ensure programming outputs meet quality, regulatory, and sponsor requirements.
Participate in sponsor audits and internal quality reviews.
Maintain inspection-ready documentation and validation records.
Training and Team Development
Mentor and train junior and mid-level programmers.
Provide technical guidance and best-practice recommendations.
Support onboarding and professional development initiatives.
Lead knowledge-sharing sessions and departmental training activities.
Stakeholder Collaboration
Collaborate with project managers, clinical data managers, programmers, sponsors, and cross-functional teams.
Participate in study kickoff meetings, project reviews, and stakeholder discussions.
Clarify technical requirements and finalize programming specifications.
Support client-facing activities and study implementation meetings.
Required Qualifications
Education
Bachelor's Degree in Computer Science, Statistics, Life Sciences, Pharmacy, Biotechnology, Clinical Research, Information Technology, or a related discipline.
Equivalent combination of education and relevant industry experience may be considered.
Experience Required
Fresher Eligible: No
Required Experience: Minimum 6+ years of experience in DM SAS Clinical Programming.
Preferred Experience
Lead programmer experience across multiple clinical studies.
Oversight and management of 4–5 or more concurrent studies.
Experience in clinical data management and clinical programming environments.
Experience supporting global clinical research programs and sponsors.
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Japan | Saitama |Tokyo :
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Sweden |Taipei :
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Warsaw |