SAS Programmer

• 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 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.
• Influences communication toward common understanding and actionable results.
• Tackles difficult problems; Identifies solutions and help leading decisions to resolve.
• Manage and deliver assignments with quality and within timelines by being independent and proactive.

Requirements:

• Bachelor's Degree/master's degree in science, Statistics, Information Technology or equivalent combination of education and related work experience.
• 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.
• Pinnacle 21, XML and MS Office) Demonstrated ability to work independently and in a team environment.
• Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project.
• 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.
• Core essential skill sets candidates must have to be considered for the role: 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.
• Solid Statistical Knowledge.
• Good oral and written communication skills.