R&D Programmer II
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Job Location:
West Chester, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
Stefanini Group is hiring!
Exciting opportunity awaits let us help you get started!
Click Apply now or you may call Rachit Rastogi at 1 or email at for faster processing!
Position Summary:
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.
Travel Requirements:N/A
Essential Duties & 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.
- Manage 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.
Position Requirements:
- Education Required: Bachelors Degree/Masters Degree in Science Statistics Information Technology or equivalent combination of education and related work experience.
- Experience Required:
- Bachelors 5 years 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.
- Experience Preferred:
- Specialized or Technical Knowledge Licenses Certifications needed
- 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).
- I 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.
Job-Specific Competencies:
- Tackles difficult problems; identifies solutions and recommends action management.
- Influences communication toward common understanding and actionable results.
- Good oral and written communication skills.
Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives
About Stefanini Group
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Required Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
