Senior Statistical Programmer

IQVIA•Durham, NC

1d•Remote

About The Position

The Senior Statistical Programmer will collaborate with study statisticians to design data structures and specifications for ad hoc and study deliverables, including ADaM datasets, tables, figures, listings, and analysis submission content. This role involves leading the production and validation of designed output, potentially overseeing work by CROs. The programmer will ensure the quality and accuracy of clinical data for submission readiness, supporting the review of CRO-provided deliverables. Responsibilities also include leading efforts for pooled and exploratory analyses, specifying and delivering ISS and ISE datasets, and designing complex SAS programs for clinical trial data analysis in CDISC ADaM format. The role requires identifying problems, developing global tools to enhance the Statistical Programming group's efficiency, and ensuring project timelines are met with high-quality deliverables. Additional duties include supporting CR&D staff, performing integrated summaries of safety and efficacy, supporting publications and presentations, and replicating statistician analyses for quality control.

Requirements

Master’s or Bachelor’s degree in Computer Science, Mathematics, Statistics, Chemistry, Biochemistry or related life sciences field or foreign equivalent.
With master’s two (2) years, with bachelor’s four (4) years of experience in clinical programming or statistical programming utilizing SAS software including development and use of SAS Macros within the CRO or pharmaceutical environment.
Utilizing knowledge of clinical programming or statistical programming processes and standards.
Utilizing knowledge of CDISC standards (CDASH, SDTM, or ADaM).
Working in cross-functional, multicultural and international clinical trial teams.

Responsibilities

Collaborate 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.
Lead the production and validation efforts for the designed output, which may include oversight of work by CROs.
Collaborate 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).
Support the review of related deliverables when provided by CROs.
Lead requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data.
Lead the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
Lead the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group.
Work closely with clinical study teams to ensure that project timelines are met with high quality deliverables.
Support CR&D staff in data analysis requests.
Perform 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, and replicate statistician analyses for QC.