Purpose:
- Provide experienced technical expertise to develop process methodology for department to meet internal and external clients' needs. 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.
RESPONSIBILITIES
Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report 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 Statistical Programming department, for complex studies.
Fulfill project responsibilities at the level of technical team lead for single complex studies or group 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, SOP and best practices.
Provide training and mentoring to SP team members and Statistical Programming department staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries
Experience as 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 Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
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
Ability to delegate work to other members of the SP team [SPM]
Exhibits routine and occasionally complex problem solving skills
Recognizes when negotiating skills are needed and seeks assistance.
Ability to lead teams and projects and capable of managing at a group level
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Masters degree in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 5 years relevant experience; or equivalent combination of education, training and experience
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IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.