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Manager, Statistical Programming, Homebased - IQVIA Biotech

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Primary Location: Durham, North Carolina, United States Full time R1292875

Job description

IQVIA Biotech is seeking a Manager for Statistical Programming:

BASIC FUNCTIONS:

Provide management, leadership, and training for the Statistical Programming group.  Manage staffing of projects and coordinate task assignments with other IQVIA Biotech departments and/or external vendors.  Manage the Statistical Programming development processes and set appropriate standards for development and testing.   Maintain responsibility for the quality and completion of all projects within the Statistical Programming group. Develop internal tools and add-ons to facilitate the processes and work flow for Clinical Reporting, and other departments within Data Operations.  Provide input to and support for proposals and business development activities.    

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Supervise department staff:

  • Assume line management responsibility for Statistical Programming staff, conducting performance reviews, setting and regularly reviewing objectives, and developing and regularly reviewing training and development plans.
  • Ensure corporate and departmental training is documented effectively.
  • Provide leadership, mentoring and programming support for Statistical Programming staff.
  • Perform review of specifications, test data, and code as needed to evaluate performance.

Department administration:

  • Assign statistical programming leads and additional resources to projects, coordinate project tasks and resources across the Statistical Programming group, and act as backup during the Sr. Director’s absence as needed.
  • Oversee departmental administration activities such as department meetings, organizational structure, SOP training compliance, timesheet review and approval.
  • Review project budgets and staffing projections for Statistical Programming activities, and actively participate in recruitment of staff for the department.
  • Review the Statistical Programming section of proposal budgets and text.
  • Make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department.
  • Process oversight, implementation and improvement:
  • With oversight of the Sr. Director, define and maintain departmental standards, SOPs and working practices.
  • Oversee staff adherence to corporate policies and departmental processes.
  • Develop internal tools and add-ons to facilitate the processes and work flow for Clinical Reporting, and for other departments within Data Operations.  Collect user requirements, program, unit-test, and implement any generic code needed to increase efficiency and quality of deliverables.

SAS software administration:

  • Manage SAS software releases, new versions, license renewals, and documentation for all SAS servers and SAS user machines.
  • Investigate potential software bugs, recommend solutions or patches as appropriate, and provide documentation to management and project teams.

Perform project work as necessary, based upon resource demands:

  • Perform project tasks and/or lead responsibilities for Statistical Programming activities.
  • Serve as backup to staff members during absences and/or transitions.
  • May oversee multiple-protocol programs.

Perform other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of the biostatistics, programming and data management aspects of the pharmaceutical, biotechnology, and/or clinical research service industries.
  • Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
  • Demonstrated ability to select, lead and motivate technical staff.
  • Ability to supervise resources and plan long-range tasks.
  • Ability to conduct training sessions with existing training modules, and update or create new training modules as needed.
  • Knowledge of programming and validation methods, and software development life cycle.
  • Experience with SAS Base, SAS Stat, SAS Macro, SAS Graph, and ODS as well as strong data step skills.
  • Ability to manage software releases and report software issues to SAS.
  • Knowledge of relational database concepts, experience with Oracle and SQL.
  • Ability to plan long-range needs while assuming responsibility for daily details with a high degree of accuracy.
  • Ability to work creatively and independently to carry out assignments of a complex nature.
  • Ability to work effectively and cooperatively with other professional staff members.
  • Excellent organizational and program documentation skills, highly detail-oriented.
  • Commitment to state-of-the-art data management & reporting procedures, as well as technologies and relevant advancements in research methodology.
  • Willingness to learn new programming languages, new technology, and new tools that will facilitate the clinical trial process.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties.

MINIMUM RECRUITMENT STANDARDS:

  • BS in a quantitative or related field with a minimum of 6 years of work experience in programming, including 3 years SAS programming work experience. 
  • Minimum of one year experience in a management, leadership and/or mentoring role.
  • Three years work experience in the pharmaceutical, biotechnology, and/or clinical research service industry.
  • Excellent communication, interpersonal, and organizational skills.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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