Senior Clinical Programming Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Position Summary

The Senior Clinical Programming Lead is an experienced clinical trial programmer with expertise in industry standard and complex data structures programming languages and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures.

The position is responsible for providing expertise planning creation and oversight of one or more clinical programming trial activities of moderate to high complexity/criticality. Including data models for fit for purpose reporting consumption and/or CDISC submission ready SDTM tabulation packages (aCRF cSDRG etc). Creates and executes edit check programs cross and study specific reporting solutions to aid in monitoring of safety risk compliance and ensures quality data review.

Responsible for creating efficiencies in the clinical data flow using metadata driven approaches and ensuring the highest level of consistency and quality across trials they support.

Role and responsibilities

Accountable for one or more clinical programming trial activities of moderate to high complexity scope and/or criticality.

Performs comprehensive review of and provides input into project requirements and documentation. Identifies gaps proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Provides technical and project specific guidance to team members to ensure high quality and on-time deliverables in compliance with departmental processes.

Ensures latest standards are being utilized current technologies are deployed.

Responsible for planning coordination oversight and execution of team activities as appropriate and provides technical and project specific guidance to team members to ensure quality and ontime deliverables in compliance with departmental processes and procedures.

Create and/or review specifications for mapping internal data review model for fit for purpose reporting consumption and/or submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.

Responsible for creation or review of internal data model fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program or oversight of quality review checks cross and study specific reports for use by team members and consumers of data.

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