Principle Statistical programmer
Global Biostatistics
Home-based, office-based, hybrid options available
The Senior Manager, Clinical Data Integration and Standards, is a key leadership position responsible for providing functional leadership and managerial oversight for a group of Clinical Programmers who are responsible for programming and standard datasets activities. The incumbent will provide strategic direction for the development and implementation of clinical data standards ensuring quality, consistency and continuous availability of data across all clinical programs.
Job Overview:
This involves planning and coordinating the development of integrated programming solutions, serving the full spectrum of statistical programming needs.
You will provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
Key Responsibilities:
• Drives the development of programming standards to enable automated and controlled data flows and quality controlled datasets creation. Ensures access and version controlled filing of clinical data as well as archiving.
•Collaborates in the generation of an eCRF global library to ensure that collected data can be adequately mapped into standard datasets
• Leads a team of Programmers within Clinical Data Integration and Standards.
• Develops and implements a process for data integrations between systems utilized to support clinical studies.
• Establishes the framework to ensure quality and accuracy – thus submission readiness – of clinical data as required by authorities (eg, SDTM, ADaM, define.xml).
• Leads and supports projects to implement the agreed Clinical Data Standards within Clinical Development.
• Develops and conducts presentations and workshops to inform and educate stakeholders within Clinical Development on Clinical Data Standards & Programming related topics. Develops networks with external parties (key experts, contract research organizations) as pertains to Clinical Standards.
• Provides guidance on management of data storage and retrieval processes in a format that allows pooled analyses and exploration of legacy data. Collaborates with Global Biostatistics in the filing of datasets and related files for studies and submissions
• Ensures provision of SAS programming to provide ready to analyze datasets in support of Biostatistics with clinical data analyses as required, including but not limited to quality oversight and consistency of clinical data, support of ongoing clinical trial evaluation, analyses for publications and regulatory submissions, health economic evaluations, explorative data analyses for planning of new trials.
Requirements:
• Bachelor's Degree in Maths, Computer science, Statistics, or related field
• 7+ years’ Statistical Programming experience within the Life Science Industry
• Advanced knowledge of statistics, programming and/or clinical drug development process
• Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM)
• Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macros
Join IQVIA to see where your skills can take you.
• Global exposure
• Variety of therapeutic areas
• Collaborative and supportive team environment
• Access to cutting-edge and innovative, in-house technology
• Excellent career development and progression opportunities
• Work-Life Balance, with a strong focus on a positive well-being
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
