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Manager, Statistical Programming

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1260719

Descripción del trabajo

Job Summary

This position is responsible for overseeing and participating in the development and validation of datasets, tables, listings and figures across multiple clinical trials, as well as supervising individual contributors, for Clinical Solutions Group. This function includes liaising with the client to develop timelines and resource plans; working with programming leads to ensure smooth project flow and successful delivery; and identifying and pursuing initiatives to improve departmental performance.

Primary Job Responsibilities

  • Supervise individual contributors engaged in statistical programming activities
  • Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards
  • Ensure that self and staff are compliant with training requirements
  • Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs, etc.) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, 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
  • Provide performance management assessments for all direct reports
  • Provide input and review status of project and/or departmental budgets
  • Other duties as assigned

Required Skills

  • 10+ years of experience in SAS programming
  • Bachelor’s degree in Math, Stats, or Computer Science
  • 5+ years supervising and mentoring clinical programming individuals and teams
  • 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.e. understanding of safety deliverables and efficacy analysis supporting regulatory submissions)
  • Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology. Demonstrated ability to debug SAS programs
  • Project lead experience and the ability to lead programming support team while effectively managing resources and timelines
  • 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 accountability.  Problem 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
  • Ability to organize, delegate, review, and manage multiple assignments with challenging timelines
  • 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 world. The 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 way. Learn 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, 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.

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