Job type full-time
Full job description
This position is responsible for overseeing and participating in the development and validation of datasets, tables, listings and figures according to statistical plans in support of clinical trials research for clinical solutions groupThis function includes providing technical expertise in one or more focus areas; proposing and developing utilities to increase departmental efficiency and/or quality; and mentoring other team members.
Primary job responsibilities
Translate study protocol and statistical analysis plan into algorithms and specifications to achieve analysis and cdisc standards
Create and/or validate all safety and efficacy study output requirements (e.gSdtm, adam, tlfs, etc.) consistent with data definitions and specifications and relevant study documentation (e.gProtocol, sap, acrfs, etc.)
Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles
Review for consistency across studies within a project; assist with developing project conventions and verifying that conventions are followed
Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients
Ensure accuracy of database and develop database checks for routine situations and with limited supervision develop checks for non-routine situations
Manage and maintain programming specifications for sdtm, adam, analysis dataset, analysis outputs, and integration of data in support of iss/ises
Develop and provide department training for applications and standard tools
Responsible for identifying opportunities for productivity improvements and formulating proposal for new sas utilities/macros and their implementation.
Serve as sme advising biometrics leadership on promoting data quality through various software technologies, programming tools, and techniques, data standards, as well as process improvement in support of clinical data cleaning, review, and monitoring activities
Responsible for formulating proposals for new utilities and/or tools as well as presenting information on existing utilities and/or tools
Effectively mentor non-clinical programming peers’ functional operations, departmental processes, and data issues
Responsible for developing and maintaining good client relationships
Guide clients on possible options for deliverables for non-routine requests
Train and/or mentor new statistical programmers on statistical programming practices
Other duties as assigned
9+ years of experience in sas programming
Bachelor’s degree in math, stats, or computer science
Effectively understand, complete trainings, and implement all sops, guidelines, and work instructions
Work independently, exercise good judgment in interpreting, modifying, and adapting company standards, project specifications, tasks, and goals
Knowledge of pharmaceutical clinical development (i.eUnderstanding of safety deliverables and efficacy analysis supporting regulatory submissions)
Knowledge of base sas, proc report, exposure to macros, current cdisc data structures, and standardization methodologyDemonstrated ability to debug sas programs
Knowledge in the creation of define.xml, pinnacle 21, adrg, and sdrg
High degree of technical competence in sas macro programming, sas sql, xml, rtf, and pdf
Demonstrated teamwork, pride of ownership, and accountabilityProblem solving and innovative skills that demonstrate initiative and motivation
Reflect company culture through actions, attitude, and work
Extremely strong communication skills, both oral and written, with all stakeholders
Willingness to travel 10-25% within north america
At iqvia, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier worldThe advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the wayLearn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
Iqvia, incProvides reasonable accommodations for applicants with disabilitiesApplicants 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 firstname.lastname@example.org to arrange for such an accommodation.