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Clinical Programming

Company Name:
PRA International
Job Title Clinical Programming
Job Family Programming
PRA Location Charlottesville, VA
Horsham, PA
Lenexa, KS
Philadelphia, PA
Raleigh, NC
Regional North America
Victoria, British Columbia
AutoReqId 14267BR
JobDetails
The Clinical Programmer (CP) is responsible for accessing and assembling clinical data from a variety of sources, converting the data to tabulation datasets and creating derived datasets following industry and client specifications, and generating tables, figures and listings to
support analysis. Knowledge of industry-accepted standards, including CDISC SDTM and ADaM, is necessary as is the ability to use the SAS statistical programming application and other software languages and tools.
With increasing levels of responsibility depending on experience, the CP is accountable for code and output validation, time management, project specifications and documentation. An experienced CP leads clinical programming teams, which includes: workload projection, resource planning, timeline coordination and budget management. Additionally, experienced programmers provide input into technical initiatives in order to develop and improve the standard processes within Clinical Programming and cross-functional groups, and mentor clinical programmers.
Interact with PRA biostatisticians, pharmacokineticists, medical writers, clinical systems developers, and other operations staff
Produce figures and documentation of datasets, including define.xml files to support the tabulation and analysis of clinical trials.
Liaise with external data vendors (e.g. central laboratories, ECG vendors) to ensure that data is transmitted in required format.
Apply knowledge of the CDISC Standards, SDTM and ADaM.
Create derived datasets in accordance with derived dataset specifications.
Understand project budgets for clinical programming tasks and communicate potential issues to the project lead and/or functional manager.
Provide leadership of and hold accountability for clinical trials projects; handling the related technical issues to ensure standard processes are implemented and overall consistency, quality, timeline, and budget goals are achieved.
o Work may include:
Serving as primary functional representative, providing input for clinical programming projects;
Mentoring clinical programmers within a clinical trial project team;
Serving as a resource for, and interacting with, other functional areas to facilitate project timelines;
Integrated database design, documentation and implementation;
Determine the required amount of clinical programming resources and the optimal qualifications/experience of team members; communicate this to functional manager during project start-up and as needs change throughout the project.
o Allocate projects tasks appropriately among assigned resources in order to achieve target utilization rates of each resource.
Identifying and quantifying changes in scope.
Contribute to the development of planning documentation for the collection, handling, reviewing and cleaning of clinical data in order to provide a high quality clinical database. Responsibilities include reviewing annotated case report forms and data transfer agreements.
Create specification documents for handling and programming the clinical data, including:
o Data conversion specifications;
o Derived dataset specifications.
Provide input into the statistical analysis plan and creation of table, figure, and listing specifications, collaborating with the lead biostatistician in order to provide high quality statistical analyses.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.
Qualifications
(MINIMUM)
An undergraduate degree in a quantitative or scientific field, or its international equivalent from an accredited institution, or relevant work experience .
Experience using Microsoft Windows and Office.
Experience with the SAS programming language or other software languages/ tools as required.
Experience within the clinical trials or pharmaceutical industry.
Demonstrated ability to provide successful leadership of project teams, including the planning, supervision, and implementation and monitoring of programming processes.
Proven history of successful interaction with internal clients and related departments/functions in a detail oriented career or academic setting.
Knowledge of data structure standards (SDTM, ADaM).
Understanding of clinical programming within the tabulation, analysis and reporting of clinical trials.

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