IQVIA Senior Statistical Programmer (Officed based) - Novella Clinical in Raleigh, North Carolina

Description:

Novella Clinical is looking for an experienced Senior Statistical Programmer to join our growing team. Position is office-based in Raleigh/Durham, NC.

BASIC FUNCTIONS:

Maintain a leadership role in the development of departmental standards, manuals and training materials; and in the training/mentoring of junior staff members. Develop internal tools and add-ons to facilitate the processes and work flow for Clinical Reporting, and other departments within Data Operations. Develop and validate SAS programs to perform data presentation and analysis. Provide programming support to project team members and other Statistical Programmers. Perform Statistical Programmer lead responsibilities on multiple projects (number of concurrent projects and study complexity level will vary based on seniority level) .

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Departmental Leadership:

  • Under guidance from management, define and maintain departmental standards, SOPs and working practices; and lead process improvement initiatives.

  • Develop training materials and execute training in Statistical Programming activities, for new and existing staff.

  • Make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department.

  • Provide technical support and expertise to the Clinical Reporting management and staff, as described below:

  • Identify the need for generic programs, work with other programmers to collect user requirements; develop functional requirements, test plan, and other relevant documentation for generic programs.

  • Develop and maintain generic code, train Statistical Programming staff on use of the generic programs.

  • Provide programming solutions to complex SAS problems, help other programmers to debug existing code and develop programming efficiencies in new programs.

  • Keep abreast of new SAS software releases and other relevant applications; apply new programming techniques to new and existing code and share new information with other Statistical Programmers.

Project Team Lead Responsibilities:

  • Review and provide feedback on Master Plan for assigned project.

  • Review and provide feedback on QC Validation Plan.

  • Review and provide input to project timelines, and ensure that project timelines are met for both internal and external clients.

  • Attend Statistical Alignment meeting.

  • Assume responsibility for project study budget, and perform monthly time projections for each project.

  • Attend internal team meetings and relevant client team meetings as needed.

  • Archive relevant documentation and deliverables.

  • Review and provide comments on statistical analysis plan and data display documents.

  • Manage programming effort for deliverables, including coordination of programming activity among team of assigned programmers, tracking programming effort, handling installation documentation, facilitating communication with the other team members.

  • File code/output/documentation associated with client delivery to defined electronic folder structures on an ongoing basis, and perform final archival activity at study close.

  • Ensure that project tasks are completed with acceptable quality for both internal and external clients.

Statistical Programming responsibilities:

  • Assist lead biostatistician with development of programming specifications for analysis datasets and tables/listings/figures, as appropriate to the project.

  • Review and provide comments on programming specifications for analysis datasets and tables/listings/figures.

  • Review statistical analysis plan and data display documents as needed, to provide feedback on programming feasibility and efficiency.

  • Develop and/or validate analysis datasets and tables/listings/figures.

  • Perform function of unblinded statistical programmer for relevant studies, including management of unblinded programming, installation and validation activities; filing unblinded code/output/documentation; and maintaining security of restricted files.

Other responsibilities:

  • Contribute to process improvement initiatives.

  • Perform independent code review and unit testing (as needed) and utilize source code management software.

  • Develop QC test plans and complete documentation for SAS code installs in QC and Production environments as needed for Statistical Programming activities.

  • Perform other duties that may be requested by management as assigned.

Qualifications:

KNOWLEDGE, SKILLS AND ABILITIES:

  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.

  • Knowledge of programming and validation methods, and software development life cycle.

  • Experience with SAS Base, SAS Macro, and ODS as well as strong data step skills.

  • Experience with SAS/STAT and SAS/GRAPH.

  • Ability to perform multiple tasks efficiently and accurately with minimal supervision while meeting deadlines.

  • Ability to develop and conduct training sessions.

  • Ability to work independently and as part of a team.

  • Ability to learn new programming languages, technology, tools and processes.

MINIMUM RECRUITMENT STANDARDS:

Degree requirements include one of the following:

  • BS degree (or equivalent, based upon education and experience) in Computer Science, Statistics, Biostatistics, life sciences, analytical sciences or related field, and 4 years of work experience in SAS programming, preferably in a clinical environment.

  • Masters-level degree in Computer Science, Statistics, Biostatistics, life sciences, analytical sciences or related field with a minimum of 2 years of work experience in SAS programming, preferably in a clinical environment.

  • Excellent communication, interpersonal, and organizational skills.

EEO Minorities/Females/Protected Veterans/Disabled

Primary Location:

USA-North Carolina-Morrisville

Other Location(s):

USA-North Carolina-Research Triangle Park, USA-North Carolina-Raleigh, USA-Ohio-Columbus, USA-North Carolina-Wilmington