Clinical SAS Programming

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timePosted 5 days ago location United States salarySalary undisclosed
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Job Description

Work from Home Available POSITION SUMMARY A Senior Statistical Programmer is an expert in the management, technical oversight, and quality of statistical programming activities related to the analyses of clinical trial data ensuring timelines and company strategic objectives are met. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable. ESSENTIAL FUNCTIONS Lead all aspects of the statistical programming activities including Efficient programming techniques. Creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs. Contribution to and review of statistical analysis plans and analysis datasets specifications. Prepare the electronic submission of clinical trial data to regulatory authorities. Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project. Provide effective solutions for complex statistical programming tasks. Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDMADaM, and e-submissions). Create and manage the project and study electronic subdirectories ensuring consistency in structure. Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency. Participate in the development of new processes or revision of existing processes. Keep current with new statistical programming techniques and technological advancements. As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex statistical programming techniques. EDUCATIONEXPERIENCE REQUIREMENTS Bachelorrsquos Degree in StatisticsBiostatistics, Computer Science, or Mathematics. 5+ years of experience as a statistical programmer in the pharmaceutical industry. REQUIRED COMPETENCIES ndash KNOWLEDGE, SKILLS, ABILITIES Working knowledge of clinical research, Good Clinical Practices, and regulatory requirementsguidelines. Technically strong with regard to statistical programming processes and activities. Highly proficient in SAS. Experience as a lead statistical programmer on several concurrent projects. Understanding of CDISC STDMADaM guidelines. Excellent English verbal and written communication skills good organizational and interpersonal skills. WORKING ENVIRONMENTPHYSICAL REQUIREMENTS The moderate use of telephone and face-to-face communication requiring the accurate perception of speech. Substantial use of keyboard requiring repetitive motion of fingers and regular sitting for extended periods of time. Minimal travel is required for training and company meetings.