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**Job Function: **
Data Analytics & Computational Sciences
**Job Sub Function: **
Biostatistics
Job Category:
Scientific/Technology
All Job Posting Locations:
Beerse, Antwerp, Belgium
Job Description:
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, define.xml, 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.
**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 Savvy
The anticipated base pay range for this position is:
€72,500.00 - €115,230.00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.