Position
Experienced I Clin Programmer
Company
Johnson & Johnson Innovative Medicine
Location
High Wycombe, Buckinghamshire, United Kingdom
Job Function
Data Analytics & Computational Sciences
Job Sub Function
Biostatistics
Job Category
Scientific/Technology
Employment Type
Full‑time
Seniority Level
Not Applicable
Responsibilities
The Experienced Clinical Programmer is an experienced clinical trial programmer with in‑depth knowledge of industry standard and complex data structures, programming languages, and reporting solutions, and has proven technical capabilities in leading clinical trial activities and teams in accordance with departmental processes and procedures.
* 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 overall quality of deliverables.
* Ensures latest standards are utilized and current technologies are deployed.
* Creates and/or reviews specifications for mapping internal data review models for fit‑for‑purpose reporting and submission‑ready CDISC SDTM, designing mapping algorithms for nonstandard conversions.
* Responsible for creation or review of internal data models for fit‑for‑purpose reporting consumption and submission‑ready CDISC SDTM packages for health‑authority submissions, keeping abreast of changing regulatory requirements. Oversees quality review checks and study‑specific reports for use by team members and data consumers.
* May programmatically aggregate clinical data sources into custom data models for fit‑for‑purpose consumption and study‑specific report solutions, performing appropriate quality control and verification to support assigned reporting activities.
* Supports and/or leads development and implementation of process, system, and tool improvement initiatives within compliance with departmental processes and procedures.
Required Skills
* Advanced Analytics
* Analytical Reasoning
* Biological Sciences
* Biostatistics
* Clinical Trials
* Data Modeling
* Data Privacy Standards
* Data Quality
* Data Savvy
* Detail‑Oriented
* Good Clinical Practice (GCP)
* Report Writing
* Research Ethics
* Researching
* Statistical Analysis Systems (SAS) Programming
* Statistics
* Technologically Savvy
Preferred Skills
Preferred candidates tend to have additional experience with broader statistical methods, advanced analytics, and emerging biostatistics technologies, in addition to the core requirements listed above.
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