Clinical Programmer

Location: Parsippany, NJ (100% remote in the United States)

Industry: Pharmaceutical

Hours: Monday-Friday, 8am-5pm Eastern Time Zone, 100% remote

Salary: $62.00/hr.-$73.00/hr. depending on experience

Employment Type: Contract up to two years depending on business needs

Environment: Pharmaceutical company that develops, manufactures, and markets generic and specialty medicines, including innovative treatments in areas like neuroscience, respiratory, and pain care. The company focuses on providing access to quality generic and biosimilar medicines while also pursuing innovation in therapeutic areas to improve global health outcomes.

Position Summary

The Clinical Programmer (SDTM) is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials. One will work independently and manage 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.

Responsibilities

• Primarily works at the study, product / program level
• Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) 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 TLGs.
• 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 (datasets and associated TLGs) 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

• Expert level of programming skills and problem resolution in SAS.
• Advanced knowledge of government regulations (such as CDISC and ICH guidelines) pertaining to drug development in multiple therapeutic areas.
• Tackles difficult problems; Identifies solutions and help leading decisions to resolve.
• 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) Inspection deliverables).
• Manage and deliver assignments with quality and within timelines by being independent and proactive.
• Solid Statistical Knowledge.
• Bachelor s Degree/master s 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, TLGs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
• Demonstrated ability to work independently and in a team environment.

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.
• EOE/ADA
• IND123