• Principal Statistical Programmer-I coordinate and act as a statistical subject matter expert for any phase of clinical trial study and/or review of programming deliverables.
• Ensure all work is processed on time with best quality, oversee programming team activities and provide technical and project specific guidance to team members. Act as programming team lead for multiple moderate-complex studies.
Primary Responsibilities Include:
• Promote and adhere to the values of the organization, Integrity, Innovative to Differentiate, Dependable and Trusted Partner, Quality on Time and Grow Collectively
• Manage or lead project assignments and programming team by acting as point of contact with the Project Management and sponsor team to ensure smooth coordination of the projects
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Positive Clinical Practices, Regulatory Agency requirements, Company Standard procedures and policies
• Responsible for initiation of protocol and SAP discussion and actively participate in the discussion.
• Develop and/or validate specification, programming for CDISC Data Standards, TFL programming for multiple complex studies
• Develop and manage metrics on a periodic basis to enable sufficient and consistent feedback and identify improvement areas and create a training plan as required
• Identify changes to the approved project plan and manage through a change control process which reviews impact on timelines, budget and resources
• Provide inputs on baseline estimations, new business proposals and project plans as required
• To produce accurate resourcing plans in conjunction with assigned Project Team Members
• Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
• Timely completion of client specific and organization specific training documentation
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📌 Principal Statistical Programmer – I (India)
🏢 Humaneva Group
📍 India
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