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Job Function:
Data Analytics & Computational SciencesJob Sub Function:
BiostatisticsJob Category:
Scientific/TechnologyAll Job Posting Locations:
Beerse Antwerp BelgiumJob Description:
The Senior Programming Lead is an experienced programmer with an advanced knowledge of programming languages has expertise in industry standards complex data structures and programming methods having the technical capabilities in leading trial activities in accordance with departmental processes and procedures. This role is responsible for providing expertise planning and oversight of one or more programming trial activities of moderate to high complexity. The role makes decisions and recommendations that impact the efficiency timeliness and quality of deliverables and provides leadership direction and technical guidance to programming teams. This role develops cross-functional working relationship with stakeholders to shape processes and practices and contributes expertise to Delivery Unit or departmental innovation and process improvement projects. The Senior Programming Lead position combines the expertise and responsibilities in their respective programming roles making them an asset to IDARs C&SP activities.
Principal Responsibilities:
Responsible for planning programming strategy coordination oversight and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects.
Designs and develops programs in support of complex clinical data analysis and reporting activities.
Supports submission activities including but not limited to creation verification and delivery of CDISC compliant and/or non-standard data packages and reviewers guides.
Provides technical and project-specific guidance to team members ensuring high-quality efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies.
Collaborates effectively with cross-functional team counterparts vendors to achieve project goals and manages escalations independently.
Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.
As applicable oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope timelines and quality.
May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.
Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes systems and tool improvement initiatives.
Required Skills:
Preferred Skills:
Advanced Analytics Biostatistics Clinical Trials Collaborating Consulting Critical Thinking Data Privacy Standards Data Quality Data Savvy Digital Fluency Good Clinical Practice (GCP) Quality Assurance (QA) Report Writing Standard Operating Procedure (SOP) Statistical Analysis Systems (SAS) Programming Statistics Systems Development Technologically SavvyRequired Experience:
Senior IC
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