Statistical Programming Associate Director

5 - 9 years

0 Lacs

Posted:18 hours ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Role Overview: As a Statistical Programming Associate Director, you will play a strategic leadership role in ensuring the quality, timeliness, and efficiency of programming deliverables across clinical or technical projects. Your strong programming expertise, deep understanding of clinical development, and ability to lead both strategic initiatives and operational execution will be crucial in contributing to cross-functional teams and driving continuous improvement across the function. Key Responsibilities: - Lead and manage the end-to-end delivery of statistical programming for clinical trials, drug development projects, or technical initiatives. - Translate clinical protocols and development plans into statistical programming strategies and deliverables. - Ensure high quality and consistency across all programming outputs; hold internal and external partners accountable for deliverable quality. - Act as a technical subject matter expert across therapeutic areas, studies, or functions. - Lead or contribute to cross-functional process improvement or administrative initiatives. - Drive the creation and implementation of best practices to enhance efficiency, quality, and innovation in programming activities. - Develop and implement programming standards; advocate for consistent use of automation and technology. - Manage and escalate risks associated with complex or novel situations within projects or studies. - Provide programming expertise to study teams and leadership stakeholders. - Generate and drive ideas for process or technical improvements. - Support functional development through mentoring, training, and participation in recruitment efforts. - Identify and deliver practical solutions to technical and methodological challenges. - Oversee and manage programming work performed by external vendors, including Contract Research Organizations (CROs). - Influence cross-functional collaborators with expert input on programming-related topics. - Ensure compliance with relevant data standards and programming best practices. - Apply project management principles to manage programming timelines, resources, and priorities. - Contribute to resource planning and capacity management within assigned projects. - Maintain current knowledge of technical developments, regulatory guidance, and industry trends. Qualification Required: - Degree in Mathematics, Applied Mathematics, Engineering, Computer Science, Statistics, Life Sciences, or a related field. - Proven expertise in statistical programming within a clinical development environment. - Deep knowledge of the clinical trial process, regulatory expectations, and data standards (e.g., CDISC). - Strong problem-solving skills with the ability to apply programming knowledge to complex project scenarios. - Ability to manage multiple activities across a range of projects with minimal supervision. - Skilled in influencing stakeholders and team members on programming-related matters. - Effective at risk management and decision-making in complex or ambiguous contexts. - Strong project mindset with attention to timelines, deliverables, and quality.,

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