Senior Statistical Programmer

IQVIA•Durham, NC

16h•Remote

About The Position

IQVIA RDS Inc. is seeking a Senior Statistical Programmer. This role involves collaborating with study statisticians to design data structures and specifications for various deliverables, including ADaM datasets, tables, figures, listings, and submission content. The position also entails leading the production and validation of these outputs, potentially overseeing work from CROs. A key aspect is ensuring the quality and accuracy of clinical data for submission readiness, adhering to standards like SDTM and ADaM. The role supports review of CRO-provided deliverables, leads efforts for pooled and exploratory analyses, and is responsible for the in-house specification and delivery of ISS and ISE datasets. Additionally, the Senior Statistical Programmer will design and implement complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format, develop global tools to enhance group efficiency, and work with clinical study teams to meet project timelines. The role also involves supporting CR&D staff with data analysis requests, performing integrated summaries of safety and efficacy, supporting publications, and replicating statistician analyses for quality control.

Requirements

Requires a master’s or bachelor’s degree in Computer Science, Mathematics, Statistics, Chemistry, Biochemistry or related life sciences field or foreign equivalent.
Requires 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.