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Senior Statistical Programmer

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Primary Location: Durham, North Carolina, United States Full time R1279424

Job description

Position Summary:

The Senior Statistical Programmer is responsible for providing hands-on support and technical guidance on clinical study teams. The development of study and ad hoc output including, but not limited to: ADaM datasets, tables, figures and listings output and/or QC of requested output is the main focus of this role. This individual, working closely with the study statistician will be responsible for review and acceptance of vendor deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures and listings and submission packages. This individual will participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. This individual will interface with other departments (eg, Biostatistics, Data Management, Regulatory Operations, Medical Writing) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. This individual will participate in department and cross functional technology development and process improvement initiatives.

  • Collaborates with the study statistician to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Leads the production and validation efforts for the designed output, this may include oversight of work by vendors.
  • Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
  • Leads requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data.
  • Delivery of ISS and ISE datasets and associated output (tables, figures and listings).
  • Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
  • Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
  • Performs additional statistical analyses including but not limited to: support responses to regulatory agencies; generate integrated summary of safety and efficacy; support publications and presentations; support planning and reporting of clinical trials via exploratory analyses of available data; replicate sponsor statistician analyses for QC.

Qualifications:

  • Bachelor’s in Computer Science, Mathematics, Statistics or related area with relevant experience.
  • At least 6 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
  • Understanding of clinical programming and/or statistical programming processes and standards.
  • Experiences with statistical programming using the SAS software including development and use of SAS Macros.
  • Knowledge in CDISC standards (CDASH, SDTM, ADaM).
  • Ability to work effectively in a team setting, and to meet set goals by managing own timelines.
  • Ability to work in cross-functional, multicultural and international clinical trial teams.

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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