Clinical SAS Programmer:

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Our client is seeking several Clinical Programmers to work out of their Horsham, PA location. Candidates that live too far away to commute to Horsham, but have more than 5 years of Pharma/Biotech/CRO experience may be considered for a work from home based role. These positions are critical to the company’s ongoing success.

The Clinical Programmer 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 Clinical Programmer is accountable for code and output validation, time management, project specifications and documentation. An experienced CLINICAL PROGRAMMER 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.

The basic description of these roles will contain but not be limited to:

• Perform billable work in accordance with Company policies and standard operating procedures (SOPs) to provide consistent high quality deliverables.

• Have familiarity with the study protocol, the annotated case report forms, data transfer agreements, and the statistical analysis plans of assigned projects to ensure study tasks are completed in accordance with clinical trial documentation

• Produce tables, listings and datasets to support the tabulation and analysis of clinical trials.

• Accessing and assembling clinical data from a variety of sources, including data management systems and vendor data;

• Converting data to SDTM or client specific structures, following project specifications;

• Creating derived datasets using ADaM or client specific specifications;

• Generating tables and listings;

• Identifying inconsistencies or problems in the source data and reporting findings to the project lead;

• Writing, documenting and performing quality control review of programs and command files.

• Effectively utilize SAS and other software and tools as required by projects and Company process.

• Interact with Company 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.

• Achieve utilization targets.

Candidates at the appropriate level of experience will also:

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. 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.

• Allocate projects tasks appropriately among assigned resources in order to achieve target utilization rates of each resource.

• Identifying and quantifying changes in scope.

• Serving as primary functional representative, providing input for clinical programming projects;

• Overseeing and coordinating with leads/subleads for the individual trials or components of the project

• Mentoring clinical programmers within a project team;

• Serving as a resource for, and interacting with, other functional areas to facilitate project timelines;

• Integrated database design, documentation and implementation;

• Identifying and quantifying changes in scope.

• Serving as a functional representative, providing input for clinical programming initiatives;

• Serving as a resource for, and interacting with, other functional areas to improve cross functional processes.

Requirements:

- BA/BS in Computer Science, Science, or some other related field.

- 1+ year of Pharmaceutical/Biotech/CRO industry experience as a SAS/Clinical Programmer

- 5+ years of experience to be considered for the work from home option

About Workforce Integration:

Workforce Integration - Wi? is a WBENC certified Recruiting Firm that specializes in a wide range of solutions and services. Our Staff is recognized as market leaders in successfully staffing major Scientific, Clinical Research, QA & Regulatory Affairs, Engineering, and IT projects.

For more than two decades, the professionals at Workforce Integration have advanced the science of staffing. We are experts in developing staffing models which recognize and respond to the complex nature of todays changing workforce and your needs for dynamic workforce opportunities.

The Wi? formula combines intensive recruiting, screening and testing procedures, with the variables of your individual needs such as Contract or Direct Hire placement; and match that with continuously evolving skill-set requirements & specializations.

The final solution blends all of these factors with marketplace demands for innovation, proven performance and the most current expertise to achieve Workforce Integration.

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