Website Intelliswift Software Inc
Intelliswift Software Inc
Company : Intelliswift Software Inc
Job Description:
Title: Senior Statistical Programming, Consultant
Location: Santa Monica, CA Hybrid/Remote
Duration: 8 Months Assignment- Contract
JOB DESCRIPTION:
We are seeking a highly motivated individual to join us as a Senior Statistical Programming Consultant.
Statistical Programming – Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of regulatory, scientific and business objectives.
Responsibilities (include but are not limited to):
• Generates or production of programming deliverables (e.g., datasets, tables, figures, listings) for study reports and integrated summaries using statistical analysis systems (i.e. SAS®). Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Perform data manipulation techniques and implement basic macro language to facilitate listing and table generation and verification.
• Performs quality review of analysis dataset and TFL programs developed by other programmers and biostatisticians.
• Coordinate programming activities for several clinical research studies or projects.
• Demonstrated ability to work efficiently and produce quality results under time constraints.
• May serve as the statistical programming lead on internal study team and coordinates programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures.
• Facilitate advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department.
• Work independently to carry out assignments with little direct supervision.
• Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams.
• Ensure the efficiency, quality, and integrity of data reporting, and project activities executed.
• May lead and organize project programming teams, typically for multiple protocol or otherwise complex projects.
• Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams.
• Communicate accurate and timely status updates to other project team members and department management.
• Maintain awareness of project tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate Contribute to ongoing improvement of programming processes and methodology.
• Perform other duties as required by the Department..
• Demonstrates a working knowledge of industry metadata submission requirements.
Basic Qualifications:
• Undergraduate degree or higher in Biostatistics, Computer Science, or related field. Master’s degree or higher preferred.
• Minimum 8+ years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.
• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
• Knowledge of one of the statistical software packages (SAS® preferred) used to conduct statistical analyses.
• In-depth understanding of clinical programming and/or statistical programming processes and standards.
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven experience in leading statistical programming activities in clinical research.
• Previous experience in pharmaceutical research or CRO setting required.
• Excellent interpersonal, communication, problem solving, and analytical skill.