Clinical SAS Programmers

Job Description

Job Summary:

• The Statistical Programming Contractor 3 is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials.
• The statistical 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.

Duties & 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.
• 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 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.

Education Required:

• Bachelor’s Degree /Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.

Experience Required:

• Bachelors + 7 year, Masters + 6 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 (e.g. 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/Client), creation of Bioresearch Monitoring (BIMO) Inspection deliverables).
• 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.