Principal Statistical Programmer

Location: Homebased anywhere in the US Purpose: Join our FSP team today! In this role you will plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Job Details: Position: Principal Statistical Programmer Home Based Min 4+ years of CRO/Pharma Industry Therapeutic Areas: Oncology, Immunology, IDV, EDCP Key Skills: Must have expertise in R programming as well as SAS Base, and good knowledge of SAS Graph and SAS Macros. Capable of implementing more advanced statistical procedures as per specifications provided by a biostatistician. Must have excellent knowledge of CDISC standards (SDTM and ADaM). Thorough understanding of relational database components and theory. Excellent application development skills. Strong understanding of clinical trial data and hands-on experience in data manipulation, analysis, and reporting of analysis results. Good understanding of ICH E6, ICH E3, ICH E8, ICH E9, and clinical research processes. Minimum of 4+ years of experience in Statistical Programming in the pharmaceutical or medical devices industry. Good verbal and written communication skills. Ability to work on multiple projects, plan, organize, and prioritize activities. Required Knowledge, Skills and Abilities: Experience as a technical team lead directly engaging clients and coordinating tasks within a programming team. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Knowledge of statistics, programming, and/or clinical drug development process. Advanced knowledge of R programming. Base SAS, SAS/STAT, SAS Graph, and SAS Macro Language. Experience with SDTM Implementation and ADaM implementation according to CDISC Standards. Expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL. Good organizational, interpersonal, leadership, and communication skills. Ability to independently manage multiple tasks and projects. Ability to delegate work to other members of the SP team. Excellent accuracy and attention to detail. Exhibits routine and occasionally complex problem-solving skills. Ability to lead teams and projects and manage at a group level. Recognizes when negotiating skills are needed and seeks assistance. Ability to establish and maintain effective working relationships with co-workers, managers, and clients. Responsibilities: Perform, plan, coordinate, and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listings; (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients; (iii) the programming quality control checks for the source data and reporting the data issues periodically. Ability to interpret project-level requirements and develop programming specifications, as appropriate, for complex studies. Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and the Statistical Programming department for complex studies. Fulfill project responsibilities at the level of technical team lead for single complex studies or groups of studies. Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. Estimate programming scope of work, manage resource assignments, communicate project status, and negotiate/re-negotiate project timelines for deliverables. Use and promote the use of established standards, SOPs, and best practices. Provide training and mentoring to SP team members and Statistical Programming department staff. MINIMUM REQUIRED EDUCATION AND EXPERIENCE: Bachelor's degree from a reputable university, preferably in science/mathematics related fields. IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

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