The Clinical Programming (Contractor) is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials. The clinical programming contractor independently manages completed projects that involve global tasks, or cross functional teams The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing programming support for publication for our marketed drugs.
Key Responsibilities
* Primarily works at the Study, product / program level
* Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLFs) complying with regulatory requirements, departmental SOPs and work practices.
* Manages and Delivers assignments with good quality and within timelines
* Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
* Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.
* Responsible for the standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement
* Proactively communicates issues impacting programming deliverables with Stat or DM team members.
Requirements
* Bachelor’s Degree/Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
* Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
* Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.
* Strong understanding of SDTM, ADaM standards and Implementation guides.
* Demonstrated proficiency in using SAS to produce analysis datasets, TLFs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
* Demonstrated ability to work independently and in a team environment.
Functional Knowledge
* Expert level of programming skills and problem resolution in SAS.
* Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated.
* TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspections).
* Have solid knowledge of statistical models used for efficacy data analysis.
Company/Industry Related Knowledge
* Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
* Tackles difficult problems, identifies solutions and recommends action management.
* Influences communication toward common understanding and actionable results.
* Good oral and written communication skills.
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