Senior Statistical Programmer, IQVIA RDS Inc. Durham, NC. May telecommute (work from home) from anywhere in U.S. and report to Durham, North Carolina location. Serve as the programming lead across multiple clinical studies, overseeing the development and delivery of high-quality statistical programming outputs. Design and implement clinical data standards using CDISC frameworks, including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets. Produce and validate statistical outputs such as tables, listings, and graphical summaries (TLFs) for clinical trial documentation and regulatory filings. Apply regulatory knowledge to ensure compliance with submission standards (e.g., FDA, PMDA, EMA). Apply SAS programming knowledge to solve problems related to non-routine situations. Understand, own and author the programming specifications and database definitions. Validate work of other programmers. Adhere to all department-specific and project standards and SOPs. Perform all responsibilities associated with SAS Programmer roles. Assist Programmers of the team in their day-to-day activities. Act as an escalation point for Programmers. Provide mentorship and technical oversight to junior programmers, promoting best practices in code development and validation. Communicate with the sponsor as needed to ensure high quality and on-time deliverables. Recommend and develop project standards. Create/review programming plan, specifications for datasets and TLFs. Contribute to process optimization initiatives and the development of reusable programming tools and macros. Conduct plausibility and completeness checks of programming output across each study. Lead and own identified opportunities for process improvement. Identify, build and validate SAS Macros. Contribute to activities in validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools. Contribute to the development and implementation of programming standards and conventions. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Collaborate closely with cross-functional teams including Biostatistics, Clinical Operations, and Data Management to define programming strategies and timelines. Support data queries from other functional groups. M-F, 40 hrs per week. Salary Range: $139,214 - $165,700/year.
Requires a Master’s or Bachelor’s degree in Computer Science, Statistics or related field, or foreign equivalent. Requires if Master’s two (2) years, if Bachelor’s four (4) years of statistical programming experience to include (if Master's two (2) years, if Bachelor's four (4) years): utilizing knowledge of the clinical drug development process; clinical programming standards including CDISC, SDTM, TLFs, and ADaM; computing applications including Base SAS, SAS/STAT and SAS Macro Language; programming, developing, and validating standard datasets, tables, listings and figures using SAS; data manipulation, reporting and automation; and (if Master’s one (1) year, if Bachelor’s two (2) years): clinical data standards and regulatory submission requirements, including define.xml and CTD packages. Apply: Ref#118142.
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
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
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The potential base pay range for this role is $139,214 - $165,700 The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.