OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Statistical Programming Consultant in Santa Monica, CA. The Senior Statistical Programming Consultant role will 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. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
• 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.
• Responsible for programming activities within a project or equivalent.
• Interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Demonstrates a working knowledge of industry metadata submission requirements.
EXPERIENCE
• Minimum 8+ years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.
EDUCATION
• Undergraduate degree or higher in Biostatistics, Computer Science, or related field. Masters degree or higher preferred.
To be a best-fit your strengths must include:
• 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.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.