Principal Statistical Programmer
Summary: Make a significant impact on clinical trial studies for a biopharma company, working in the area of Rare Disease. Be highly involved in sponsor-side programming activities including SDTM review, vendor oversight, ADaM/TLF programming, macro development, integrations and submission deliverables. IQVIA is hiring for a sponsor-dedicated (FSP) team as a Principal Statistical Programmer, working fully within the sponsor environment.
Development of study outputs including SDTM/ADaM datasets, tables, listings, figures and QC of requested output.
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.
Interact with internal departments of the sponsor - Biostatistics, Data Management, Regulatory Operations and Medical Writing.
Collaborates with peers and statisticians to ensure the submission readiness of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
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; replicate vendor and statistician analyses for QC.
Our expectations of you:
8 years or more in SAS programming for clinical trial data.
Bachelor’s degree in Math, Stats, Computer Science or related.
Strong knowledge in CDISC standards (SDTM, ADaM).
Previous experience acting as a lead of programming activities and timelines.
Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.
Knowledge of pharmaceutical clinical development - understanding of safety deliverables and efficacy analysis supporting regulatory submissions.
Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.
High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.
Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.
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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